Recording a state of a medical device

ABSTRACT

A system and method of recording a state of a medical device having a disposable component includes operating the medical device to provide a medical procedure using a disposable component. The disposable component is installed on an external surface of the medical device housing by a human operator and removable therefrom for disposal. The system and method include detecting an error condition on the medical device and, in response, acquiring an image from a camera coupled to the medical device. The image, representing the disposable component and the external housing, is stored in a memory of the medical device and is accessible for later retrieval.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. app. Ser. No.16/261,637, filed Jan. 30, 2019, which is a continuation of U.S. app.Ser. No. 15/305,260, filed Oct. 19, 2016, which is the National Stage ofInternational Application No. PCT/US2015/030602 filed May 13, 2015 andwhich claims the benefit of the following U.S. provisional patentapplications: U.S. App. No. 61/993,446 filed May 15, 2014, U.S. App. No.62/106,317 filed Jan. 22, 2015, U.S. App. No. 62/088,093 filed Dec. 5,2014, U.S. App. No. 62/106,312 filed Jan. 22, 2015, U.S. App. No.62/134,658 filed Mar. 18, 2015, U.S. App. No. 62/106,300 filed Jan. 22,2015, U.S. App. No. 62/106,296 filed Jan. 22, 2015 and U.S. App. No.62/079,628 filed Nov. 14, 2014, all of which are expressly incorporatedherein by reference in their entireties.

BACKGROUND

The present application relates generally to recording a state of amedical device. The present application relates more specifically torecording an image of a disposable component used with a medical devicefor diagnostic purposes.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of an optical head-mounted display device,according to an illustrative embodiment;

FIG. 1A is a drawing of a frame for a head-mounted display device,according to an illustrative embodiment;

FIG. 2 is a block diagram of a medical facility having a medical device,head-mounted display device and server computer communicating over anetwork, according to an illustrative embodiment;

FIG. 3 is an illustration of a head-mounted display for displaying aninstruction relating to the medical device, according to illustrativeembodiment;

FIG. 4A is an illustration of a head-mounted display for use in amedical facility, according to illustrative embodiment;

FIG. 4B is an illustration of a head-mounted display for use in amedical facility, according to illustrative embodiment;

FIG. 5 is a diagram of a head-mounted display device for comparing acharacteristic of a medical device with predetermined data for thecomponent, according to an illustrative embodiment;

FIG. 6 is an illustration of a head-mounted display device for a patientidentity check, according to an illustrative embodiment;

FIG. 7 is an illustration of a head-mounted display device for recordingmedical device information in response to a notification message,according to an illustrative embodiment; FIG. 7A shows exampleinterfaces for blood collection device operators who are wearing a headmounted display device, according to an illustrative embodiment.

FIG. 8 is an illustration of a head-mounted display device fordetermining a characteristic of blood flowing through a component ofmedical device, according to an illustrative embodiment;

FIG. 9 is a series of screens displayed by a head-mounted display devicefor interface with a medical device configured to remove blood from apatient, according to an illustrative embodiment;

FIG. 10 is an illustration of a head-mounted display device forauthorizing a feature based on visual cues, according to an illustrativeembodiment;

FIG. 11 is a flowchart of a method of recording a state of a medicaldevice, according to an illustrative embodiment;

FIG. 12 is a flowchart of a method of recording a state of a medicaldevice, according to an illustrative embodiment;

FIG. 13 is a medical device for recording an image in response to adetected error condition, according to an illustrative embodiment;

FIG. 14 is a medical device for recording an image in response to adetected error condition, according to a second illustrative embodiment;and

FIG. 15 is a medical device for recording an image in response to adetected error condition, according to a third illustrative embodiment.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring now to FIG. 1, an optical head-mounted display device 10 isillustrated, according to an illustrative embodiment. Device 10comprises a frame 12 configured to be mounted to a user's head, e.g.,comprising a frame configured to hold lenses in front of the eyes. Theframe (e.g., FIG. 1A) may comprise one or more of eye wires or rimssurrounding and holding the lenses in place, a bridge which connects twoeye wires, a top bar above the bridge for structural support, nose padsfor resting of the eye wires on the nose, pad arms which connect the eyewires to the nose pads, hinges configured to provide swivel movement,elongated pieces for extending to the ears, curved and/or resilientearpieces for contact with the ears, etc. Embodiments may comprise anelastic headband, helmet, hat, or other components. One or more of thecomponents shown in FIG. 1 may be attachable to a wearable frame 12 ormovable to different locations on a wearable housing.

A processing circuit 14 comprises analog and/or digital electricalcomponents configured or programmed to perform any of the functionsdescribed herein, including drivers, buffers, amplifiers, etc.Processing circuit 14 may comprise one or more microprocessors,microcontrollers, application-specific integrated circuits, programmablelogic devices, etc., which may further be programmed by way of anoperating system, applications, and/or other computer programs stored ona tangible memory device. Memory 16 may comprise RAM, Flash, volatileand/or non-volatile memory of a variety of types used to supportprocessing circuit 14 in executing its functionalities.

A display 18 is driven by processing circuit 14 to display data to auser. The display may be disposed directly in front of the eye of theuser. The display may be monocular or binocular. Display 18 may be anoptical head-mounted display which may be configured to provide imagesto a user and to allow the user to at least partially see through thedisplay or a portion thereof. Display 18 may comprise a projectiondisplay, such as a prism projector, optical waveguide, microdisplay, orother display technology to provide an illusion of an image of an X-inchdisplay at a Y-feet distance, where X and Y are variable depending onthe design of the display system.

A sound transducer 20 may be configured to provide audio data output tothe user. Sound transducer 20 may be an audio speaker, a bone conductiontransducer, or other sound transducer.

A camera 22 is configured to acquire light in the form of images andvideo and to provide the acquired image data to processing circuit 14.Camera 22 may comprise a forward-facing camera configured to acquireimages from in front of the user, a backward-facing camera to acquireimages from behind the user, and/or other cameras, such as a camerapointed at the user's eye to detect eye movements or othercharacteristics of the eye. Acquired images, video, and/or sounds may bestored in memory 16 and/or transmitted via transceiver 26 to a remotedevice, such as a desktop computer, laptop computer, or smartphone.

Transceiver 26 may comprise one or more wired or wireless transceivercircuits configured to transmit and receive data between device 10 andother computing devices. Transceiver 26 may comprise technology for widearea networks, local area networks, personal area networks, or othernetworking, such as communications according to a Bluetoothspecification, an IEEE 802.11 specification, a Wi-Fi or Wi-Maxspecification, a cellular specification, a Universal Serial Busspecification, a near-field communication specification, etc.

A microphone 24 is configured to receive audible signals from neardevice 10 and may be directed and configured to receive spoken commandsfrom a user wearing device 10. Processing circuit 14 may be configuredto operate a speech recognition algorithm, such as a natural languageprocessing algorithm, to recognize commands and input given orally by auser wearing device 10.

Sensors 28 may comprise any of a variety of sensor configured to provideinput to device 10 regarding the surroundings, movement, location orother characteristics of device 10. Sensors 28 may comprise one or moreof an accelerometer, gyroscope, magnetometer, ambient light sensor,proximity sensor, etc.

An input device 30 may comprise other user input devices, such as apush-button input, a touch pad input, a swipe input, hard or soft keys,etc.

A battery 32 may be rechargeable and may provide power needed formobility of device 10.

In alternative embodiments, any of the teachings herein may be appliedto other head-mounted devices, other wearable devices (such as awrist-wearable device), or other computing devices.

Any of the teachings herein can be applied to a variety of medicaldevices and procedures. In some cases, these medical procedures may beinvasive procedures performed by a medical device suitably configured.Invasive procedures include procedures that penetrate or break the skinor enter a body cavity, such as those that involve a perforation,incision, a catheterization, etc. One invasive procedure is an apheresisprocedure performed by an apheresis machine on a patient (e.g., blooddonor). Another invasive procedure is an infusion of drugs or othermedicants performed by an infusion pump. An infusion may involveintravenous therapy, or the infusion of a liquid substance directly intoa person's vein, for such treatments as electrolyte imbalance, todeliver medications, for blood transfusion or replacement, to treatdehydration, etc. Another invasive procedure is an enteral feedingprocedure performed by an enteral feeding pump. An enteral feeding pumpis configured to pump nutrients at a controlled rate and amount into thenose or abdomen of a person. Another invasive procedure is a parenteralfeeding and/or infusion procedure performed by a parenteral feedingpump. A parenteral feeding pump is configured to pump nutrients at acontrolled rate and amount in the body in a manner other than throughthe digestive canal (e.g., through injection).

Certain examples provide mobile applications for medical devicesincluding blood collection or apheresis devices, infusion pumps, drugdelivery pumps, and/or other medical devices. For example, an infusionpump infuses fluids, medication, or nutrients into a patient. Aninfusion pump can be used intravenously, subcutaneously, arterially,and/or epidurally, for example. For example, an infusion pump canadminister injections at a variety of rates (e.g., injections too smallfor an intravenous (IV) drip (e.g., 0.1 mL per hour), injections perminute, injections with repeated boluses, patient-controlled injectionsup to maximum number per hour, or injections of fluids whose volumesvary by time of day, etc.).

In some infusion pump embodiments, an operator (e.g., a technician,nurse, etc.) provides input regarding type of infusion, mode, and/orother device parameter. For example, continuous infusion provides smallpulses of infusion (e.g., between 500 nanoliters and 10 milliliters),with a pulse rate based on a programmed infusion speed. Intermittentinfusion alternates between a high infusion rate and a low infusion ratewith timing programmable to keep a cannula open, for example.Patient-controlled infusion provides on-demand infusion with apreprogrammed ceiling to avoid patient intoxication. The infusion rateis controlled by a pressure pad or button that can be activated by thepatient, for example. Infusion pumps can include large volume pumps(e.g., for nutrient solution delivery to feed a patient), small-volumepumps (e.g., for medicine delivery), etc.

Referring to FIG. 2, a medical device 104 may be a device thatadministers a medicament to subject 102, extracts fluid or tissue fromsubject 102, implants an object into subject 102, or captures a medicalimage of subject 102. For example, medical device 104 may be a dialysismachine (e.g., a hemodialysis machine, a hemofiltration machine, etc.),an infusion pump, a drug delivery system, etc. Medical device 104 may bean apheresis machine configured to draw blood from subject 102 (e.g.,subject 102 is a donor or receiver of blood components) and/or otherwiseprocess blood components from subject 102. In some implementations,medical device 104 may use measurements taken from subject 102 tocontrol the medical procedure. The measurements may be taken directly bymedical device 104 or may be received by medical device 104 via datalink or communication link 112 from a measurement device. For example,medical device 104 may use the body temperature, pulse rate, bloodpressure, respiratory rate, blood glucose level, pupil dilation, pulseoximetry information, ECG information, or other physical characteristicof subject 102 during the medical procedure.

An optical head-mounted display device 10 may capture or generate datawhich may be used for record keeping purposes, according to variousimplementations. For example, device 10 may associate a timestamp withmeasurements taken from subject 102. Similarly, medical device 104 mayassociate a timestamp with data received from device 10. In someimplementations, server 124 may receive the data from device 10 and/orfrom medical device 104 and store an electronic record of the reactionof subject 102 to the medical procedure. In some implementations, server124 may also receive operational data from medical device 104 vianetwork 122. Operational data may include any data indicative of theoperational state of medical device 104 during the medical procedure.For example, the operational data may include one or more of a fluidflow rate, a citrate infusion rate, a dosage of substance administeredto subject 102 (e.g., a dosage of medicament, saline, blood, bloodcomponent, anticoagulant, or other fluid), volume and/or componentscollected, or other data. In some implementations, the operational datamay be time stamped, allowing a record of the operation of medicaldevice 104 to be generated. Medical device 104 may be configured to timestamp the operational data at periodic or intermittent intervals, e.g.,at least every 10 minutes, at least every 15 minutes, etc.

Server 124 may be any form of computing device or set of computingdevices configured to store and communicate electronic data. Forexample, server 124 may be a personal computer, a mainframe, acloud-computing environment, or a data center. Server 124 may include aprocessing circuit that includes a processor 126 and a memory 128 thatstores instructions for processor 126. Server 124 may also includeinterface circuit 130 configured to communicate with network 122 via awireless or hardwired connection, according to various implementations.

Network 122 may be any form of computer network that relays informationbetween medical device 104, server 124, and/or a head-mounted device 10.For example, network 122 may include the Internet and/or other types ofdata networks, such as a local area network (LAN), a wide area network(WAN), a cellular network, satellite network, or other types of datanetworks. Network 122 may also include any number of intermediarycomputing devices (e.g., computer, servers, routers, network switches,etc.) that are configured to receive and/or transmit data within network122.

Server 124 may receive and store data generated by device 10 and/oroperational data generated by medical device 104 in memory 128, in someimplementations. In further implementations, memory 128 may storeinformation about subject 102 and provide subject data to medical device104 and/or device 10. For example, subject data may include demographicsinformation about subject 102 (e.g., height, weight, gender, etc.),medical information about subject 102 (e.g., allergies, symptoms,diseases, medical conditions, etc.), or other information that may beprovided to other electronic devices by server 124. In someimplementations, medical device 104 may adjust its operation based inpart on subject data received from server 124. Server 124 may alsoprovide installation data to medical device 104 via network 122 (e.g.,to install, update, and/or remove software loaded in memory 154 ofmedical device 104). Server 124 may be configured to communicate withmedical device 104 and/or device 10 via any number of differentnetworking protocols. For example, server 124 may communicate withmedical device 104 and/or device 10 via an HTTP connection, FTPconnection, SSH connection, a telnet connection, combinations thereof,or other similar networking protocols. In some implementations, server124 may relay data between medical device 104 and another electronicdevice. For example, server 124 may be a device that communicates withmedical device 104 within the same medical facility and relaysinformation between medical device 104 and a server of the manufacturerof medical device 104 via the Internet.

Referring to FIG. 3, a head-mounted display for displaying aninstruction relating to the medical device will be described, accordingto illustrative embodiment. A head-mountable display device 300 has aframe 301 configured to be mounted to a person's head, e.g. as a pair ofglasses, a display 302, and one or more other components or featuresdescribed herein, such as processing circuit 303. Device 304 is amedical device configured to perform an invasive procedure on a patient,in this case an infusion of a medication 306 into a patient (not shown).

In this embodiment, processing circuit 303 is configured to receiveinput data relating to the medical device. For example, the input datamay be a ping or message comprising notification data from device 304indicating a condition or state of device 304 (e.g., an occlusion hasbeen detected by device 304 in a line or tubing 305.) In anotherexample, the input data may be an image of at least a portion of device304 acquired by a camera 308 coupled to frame 301 mechanically and toprocessing circuit 303 electrically. In this example, the camera isconfigured to acquire an image of medical device 304 in response to userinput at a user input device 310 (e.g., a touch pad, a hard key, a softkey, etc.). The user may choose to acquire an image after seeing anerror message 312 or other notification 314 on a screen of medicaldevice 304, after hearing an audible alarm, etc. Alternatively, thecamera may automatically, without requiring user input, acquire one ormore images or video of medical device 304 at periodic or intermittenttimes, continuously, or in response to a wireless message received fromdevice 304 sent when an alert, alarm or other condition is detected bydevice 304. Processing circuit 303 may operate a text recognitionalgorithm (e.g., optical character recognition, etc.) to identify thepresence and/or content of a condition of medical device 304 warrantingthe acquisition of an image or other input data. Processing circuit 303may be configured to detect a condition of the medical device from anacquired image and to generate the input data used to retrieve theinstruction relating to the medical device. For example, from anacquired image, processing circuit 303 may be configured to determineone or more of a make, model or type of medical device, an error codedisplayed on a screen of device, one or more alert lights beingilluminated, a bar code or QR code displayed on the screen, textualmessages displayed on the screen, etc. Processing circuit 303 may thengenerate a request message comprising one or more of these determineddata and transmit the request message to a remote computer using itswireless transceiver to request information. Processing circuit 303 maymake such a determination by comparing at least a portion of theacquired image with data in a database configured to store informationregarding a plurality of different types of medical devices.

Upon visual identification by device 300 of an error, alarm, or otherissue, or upon request of a user or receipt of other input data (e.g.,from another computer), processing circuit 303 is configured to retrievefrom a memory an instruction relating to the medical device based on theinput data, and to display the instruction relating to the medicaldevice on display 302. The memory may be local to device 300 or remote(e.g., a server-based memory, cloud-based memory, etc.). The instructionmay comprise a plurality of instructions, e.g., step-by-stepinstructions, displayed and/or heard by a user for procedures, serviceof the instrument, programming the instrument, entering a test mode ofthe instrument, responding to alarms, how to program the device, etc. Asshown in FIG. 3, the instructions “open door” and/or “remove line” maybe provided to a user in response to device 304 detecting an occlusion.The instruction may alternatively comprise a sound relating to theinstruction output by a sound transducer of device 300, such as voiceinstructions to the user.

In one embodiment, the instruction comprises at least three step-by-stepinstructions, wherein the processing circuit is configured to displayeach of the at least three step-by-step instructions in a sequence, oneafter the other, on subsequent screens on display 302. A user maycontrol the display of each screen by pressing input device 310 to moveon to the next screen (or back to a previous screen), or using voicecommands such as “next screen” or “next instruction” or “complete,”which are interpreted by a speech recognition algorithm operated byprocessing circuit 303.

The instruction may relate to troubleshooting a problem encountered withthe medical device, which may comprise one or more instructions to theoperator of the device to try different actions with the device todiscover and/or solve or address the problem. The instruction mayinstruct a user how to respond to an alarm or alert generated by themedical device.

In another embodiment, the instruction may be a training instructionconfigured to train the person how to use the medical device, such as,an introduction to the features and functions of the device, a review ofoperating instructions, information about new features downloaded to thedevice by way of a software update, etc. The training instruction may bepresented on the display and may further be related to a screen beingdisplayed on the medical device approximately simultaneously, so thatinformation provided to the operator by device 300 and the mode ofmedical device 304 is at least partially synchronized. For example, ascreen may appear on device 304 allowing the operator to begin aninfusion. Device 304 may also send a message to device 300 providing aninstruction as to which button the user should press to begin theinfusion. Processing circuit 303 may further display an icon, such as anarrow, pointing to a button on device 304 to be pushed, as seen througha point of view of the person wearing device 300. Device 303 may directthe user to align their point of view with the screen of device 304using arrows or audible instructions to direct the person's gaze. Upondetecting that the user's view is suitably aligned, device 303 mayprovide the icon or other indicator showing the person which button topush. In another embodiment, display 302 may cover substantially all ofa lens or both lenses of head-mounted display device 301 and processingcircuit 303 may be configured to align indicators on display 302 withareas of device 304, as seen from the perspective of the user of device301. This alignment may be based at least in part on image data receivedfrom camera 308 of device 304. An augmented reality display may beprovided using such a system in order to overlay indicators, text,highlighting, etc. over one or more portions of device 304 as seen froma field of view of a user of device 301.

In another embodiment, the instruction may comprise a video configuredto train a patient about a procedure to be implemented using the medicaldevice. Device 300 may comprise a sensor (e.g., camera (IR, visiblelight, ultraviolet light, etc.), microphone, ultrasound sensor, etc.)configured to sense a condition of a patient when the patient is wearingthe device, such as the patient's blood pressure, a facial expression,heart rate, etc. Training on medical device 304 can by synchronized witha donor video displayed on display 302. Donor reactions and actions canbe synchronized with a training simulation (e.g., what a donor does whenan occlusion occurs, when there is low pressure in the device, etc.).Reactions may include the patient closing their eyes, fainting, changingskin color, getting agitated, moving in a certain manner, etc.Processing circuit 303 may use camera 308 to detect and/or record any ofthese reactions or actions by the patient and to store them and/oranalyze them. Any medical device training simulation with a patient mayuse one or more of these concepts.

In another embodiment, device 300 may comprise a sensor configured tosense a motion or eye position of the person wearing the head-mounteddisplay unit 300 (e.g., a forward-facing or user-facing camera) and togenerate control signals for controlling the medical device based on thesensed motion or eye position. Display and/or sounds may be initiated byuser motion and/or eye control, as detected by the sensor and processedby processing circuit 303 to generate control messages sent to device304. In one embodiment, any touch point or input device (e.g., point ona touch screen, hard or soft button, etc.) could be controlled by eyemovement/location and a blink to confirm. Device 300 and/or device 304may comprise imaging hardware or other programmed circuit which recordsa digital portrait of the user's eye. Using the information about theuser's eye, device 300 and/or device 304 may be configured to calculatethe approximate location of the user's eye-gaze on a display screen ofdevice 304. Device 300 and/or device 304 may then be configured toexecute commands associated with an input device (e.g., menu option,“OK” button, “Back” button, etc.) currently displayed at this screenlocation. In this way, the user can interact with device 304 by lookingat an appropriate sequence of menu options displayed on the screen.

In another embodiment, device 300 and/or device 304 may be configuredwith a voice processing circuit to receive voice commands for adjustingsettings or selecting settings on device 304. The voice processingcircuit may be configured with a security feature such as voicerecognition which has been taught to the circuit during a trainingoperation, in order to authorize only vocal commands from a certainperson or persons. In one example, device 300 is configured with thevoice processing circuit, including training, authentication, conversionto commands, etc., though in alternative embodiments, one or more ofthese functions may be operable on device 304 or distributed betweendevices 300 and 304.

In various embodiments, portions or all of reference files (e.g., usermanuals, service manuals, instructions for use, trouble-shooting guides,community support websites, FAQs, etc.) for procedures, devices,hospitals, blood centers, etc. may be displayed on demand on display302. Directions or reference materials may be displayed in real timebased on a ping from medical device 304. In one example, instructionsfor use may be provide to assist an operator in setting up a disposablekit. A camera on device 300 may scan a disposable unit installed on theinstrument 304 by the operator. A video processing circuit on device 300may be configured to detect that a clamp on device 304 is closed when itneeds to be opened for proper functioning of instrument 304 with thedisposable unit. Device 300 may be configured, in response to thedetection, to display the color red as an icon, background, or otherportion of the display. Device 300 may then be configured to retrievefrom a memory a picture or video of the disposable unit/kit properlyinstalled and zoom in on the clamp that needs to be open. The heads-updisplay could show a GIF (Graphics Interchange Format) file or videofile of the clamp being opened, optionally along with textualinstructions such as “open this clamp.” Additional instructions, such as“try again,” “correct,” etc. may be displayed in response to anoperator's actions with respect to the disposable unit as viewed by thecamera of device 300. The screen may provide a green icon, background orother portion of the display, optionally along with a textual message,to indicate the disposable unit is properly installed. In anotherexample, a camera on device 300 may scan a patient before, during orafter a procedure is carried out on the patient using device 304. Avideo processing circuit on device 300 may be configured to detect ornotice any of a number of patient conditions, such as any of a number oftypical drug allergy symptoms (e.g., skin rash, hives, fever, swelling,watery eyes, etc.). In response, a heads-up display on device 300 may beconfigured to flash a red color as an icon, background, or other portionof the display. The heads-up display may be configured to display one ormore text messages, such as “IMMEDIATE RESPONSE IS REQUIRED!” and/or“DRUG REACTION.” The heads-up display may be configured to retrieve froma memory an instruction, such as a text, video, GIF, etc. to assist theoperator in how to respond to the symptoms detected, which may includeinstructions for how to safely shut down the procedure.

Referring to FIG. 4A, a head-mounted display for use in a medicalfacility will be described, according to illustrative embodiment. Inthis embodiment, a person wearing the head-mounted display device 400has a view of the medical facility relative to the frame. Some of theview is through the display 402, while another portion of the view isthough a lens of frame 401.

A processing circuit 403 is configured to receive information regardinga location of a medical product or patient in the medical facility via awireless transceiver 409. For example, the location may be a geolocation(e.g., comprising a latitude, longitude and/or altitude), a room withina building (e.g., Room 101 on the first floor, Room 202 on the secondfloor), a location within a room (e.g., closet A in Room 101, closet Bin Room 101), relative locations (e.g., to your left, to your right,above you, 90 degrees right and 40 meters away, locations using anycoordinate system such as Cartesian, polar, cylindrical, etc.), or otherlocations. The location information may be received from a databaseremote from device 400, for example an inventory database comprisingdata regarding instruments, kits, donors, patients, products, disposablecomponents, medical devices, machines, medical supplies, etc., and theirrespective locations. The inventory database may comprise inventoryinformation about one or more medical device components (e.g., aninfusion or enteral feeding pump or component thereof, an apheresismachine or component thereof, a disposable component (e.g., a kit,cassette, tubing, blood transfusion bag, etc.), etc.). The inventorydatabase may comprise one or more server computers accessible via theInternet or another network. The inventory database may be accessiblevia a direct network connection (wired or wireless) between device 400and the database.

Additional information, such as quantities, suppliers, SKUs, modelnumbers, serial numbers, personal information, and/or ID numbers, etc.for the items or people may also be stored in the database. Part or allof the database may be stored in local memory on device 400. Thedatabase may be used for inventory control and/or tracking within themedical facility and may be accessible by one or more computers,including device 400. The database may further be configured to providerservices for a network of medical instruments, such as backup andrecovery data services, remote programming services, software updateservices, etc. For example, the database may be part of a computersystem configured to program different medical devices to operatedifferent blood processing procedures for different patients. Thecomputer system may collect records of blood processing proceduresperformed for patients on the different blood processing machines andmake the records available in report format or for viewing on a separatecomputer. The computer system may be configured to run diagnostic testson the blood processing machines in response to an error or in a routinemanner.

In FIG. 4A, a room location 420 is shown and two object or shelflocations 422 and 424 are shown. Device 400 is configured to provide avisual indication of the location on the display. FIG. 4 illustratesthree examples of visual indications at indicators 426, 428 and 430.These visual indications may be displayed in different regions ofdisplay 402, depending on space available, the position of locationswithin the field of view through display 402 and the position oflocations within the field of view of device 400, but outside the fieldof view of the display 402. The visual indication of the location maycomprise a graphical representation in the person's view of the medicalfacility through the frame and/or in the person's view of the medicalfacility through display 402. Display 402 may comprise a display surfaceconfigured to reflect projected images representing the visual locationand to allow the person to see through the display surface into themedical facility.

Upon a person entering a room or requesting information about a medicalproduct (e.g., by speaking to device 400 through a speech recognitionengine, by pressing one or more buttons, by selecting from a menu ondisplay 402, etc.), device 400 is configured to retrieve a location ofdevice 400 and a location of the requested items. Location and/ororientation of device 400 may be calculated using a satellite navigationsystem such as a global positioning receiver, a radio navigation systemsuch as cellular tower triangulation, Wi-Fi location, near fieldcommunication (e.g., radio frequency ID) or a position determinationentity (PDE), dead reckoning navigation such as use of an accelerometer,gyroscope and/or compass, or other technologies. The location of therequested item may be manually entered into the database by inventory orpurchasing personnel. Locations may be determined with any of a widerange of accuracies, such as within 10 meter accuracy, within 1 meteraccuracy, an identification of a building, an identification of a roomwithin the building, an identification of a shelf in a room of abuilding, etc.

Having received the locations of device 400 and the medical products ofinterest, device 400 is configured to determine how to display indiciaof the locations of the medical products of interest. For example, ifthe medical products are located in another room and outside a field ofview of device 400, a textual description or other description of thephysical location can be provided, such as indicator 430. Indicator 430is displayed on display 402 and notifies or instructs a wearer of device400 that 214 kits of medical product are located in Room 101 (e.g., aphysical description) which is to the wearer's left, approximately 40feet away (namely, room 420). The physical description may representphysical objects or locations, such as room numbers or identifiers,floor numbers, building numbers, a compartment identifiers (such as ashelf, drawer, etc.), a platelet shaker, a freezer location, aparticular portable cooler (e.g., if a blood product is coming from amobile collection), a particular mobile bus number or identifier, etc.Indicator 428 is displayed on display 402 in the vicinity of or near alocation where a portion of display 402 overlays a shelf 424 where thekits are located. In this case, an indicator 428 (which may comprise agraphical indicator, such as an indicator having a two-dimensional shapesuch as an icon or other visual graphic such as an arrow, a flashinglight, etc.) is shown immediately adjacent shelf 424 with an arrowpointed toward shelf 424 indicating that 3 kits of medical product arelocated there. A third indicator 426 instructs the wearer to look 20feet to the left for another location that has 14 kits of medicalproduct remaining, namely shelf 422, which is within the field of viewof device 400 but not overlayed by display 402.

Device 400 is further configured to detect a change in the view of theperson and to change the visual indication of the location on thedisplay in response to the detected change in view. For example, as thewearer moves their head to the left to bring shelf 422 within their viewthrough display 402, the indicator 426 may change to an indicator havingthe characteristics of indicator 428, such as no distance indicator andan arrow pointed directly toward the location. As the view is changed,indicator 426 may be continually updated with a new relative position(e.g., 20 feet, 15 feet, 10 feet, 5 feet, etc.) as the view changesabout the room. The processing circuit may be configured to detect thechange in view of the person based on at least one of an accelerometerand a gyroscope. A gyroscope can be used to measure speed and/ordirection in three-dimensional space. An accelerometer can be used tomeasure changes in relative position. The processing circuit may beconfigured to detect the change in view of the person based on acalculated physical location of the device. The processing circuit maybe configured to use programmed algorithm techniques, such as perceptionof perspective and parallax. Using these techniques can give the userrealistic depth perception on a display.

In one embodiment, the medical facility is a blood donation facility,wherein the medical product comprises a blood donation kit. A blooddonation kit may comprise a blood bag, tubing and/or other componentsthat are configured for use with a single patient (e.g. a blood donor)for a single blood donation and may be considered to be disposable.

Referring now to FIG. 4B, a head-mounted display device for use in amedical facility will be described according to another exemplaryembodiment. In this embodiment, display device 400 is configured toreceive information regarding a person (e.g., a patient, a healthcareprofessional, another employee of the medical facility, a patientvisitor, etc.). Device 400 is configured to provide a visual indicationof information about the person, to detect a change in the view of thewearer of device 400, and to change the visual indication of theinformation on the display in response to the detected change in view.

Device 400 may be configured to receive information regarding the personwithin the field of view of the device wearer from any of a number ofsources, including sources local to device 400 and sources remote fromdevice 400. For example, information regarding a patient 440 may bereceived from a hospital management system database which includesrecords of patients checked into different rooms of the medicalfacility. Patient 440 may be assumed by device 400 to be the patientthat belongs in this room based on the patient record. Further, device400 may be configured to acquire an image of a portion of patient 440'sface and use a facial recognition algorithm to confirm that the face ofpatient 440 matches data in the patient record (e.g., such as aphotograph of the patient acquired at the time of check-in).

Device 400 may be configured to display on display 402 a visualindication 441 of information about patient 440, such as the name of thepatient, known allergies, procedure to be performed, last measured bloodpressure, progress of procedure (e.g., indicating a percentage orportion complete), etc. The visual indications may be textual orgraphical, may use color or flashing indicators to highlight importanceof the indications, etc. The visual indications may comprise dataacquired in real-time from a medical device 442 monitoring patient 440and/or a progress of a procedure being performed on patient 440.

Device 400 may further be configured to display visual indications 443of information about another person in the room 444. Information 443 maycomprise an identification of the person (e.g., name, title, role,etc.), an employer of the person, etc. For example, information 443 mayindicate that person 440 is a visiting anesthesiologist from a differentmedical institution. This may be a doctor that the wearer of device 400is not familiar with. Device 400 may determine the identity of person440 may acquiring an image of at least a portion of person 440's face orother biometric input, an image of a name tag worn by person 440 using atext recognition algorithm, an input from an RF ID tag or othernear-field communication device worn by person 440, or using othertechniques. This information may be used to look up further informationabout person 440 from a local memory or from a server computer for themedical facility comprising data about persons authorized to work in themedical facility. If person 440 is not authorized to work in the medicalfacility, device 400 may provide a visible and/or audible warningindication to the wearer of device 400. This feature may also be used toconfirm that visitors of patient 440 have been previously authorized tovisit patient 440 at a check-in process in which an image of theperson's face has been acquired, or the person has been giving anear-field communication device for detection by device 400.

In another embodiment, a head-mounted display may be configured todisplay a list of medical records and/or medical folders to the wearer.A user may request to view medical records by, for example, glaring at aparticular item (e.g., a file cabinet, a code printed on a wall, etc.),by using a head tilt to a predetermined direction, by providing a voicerequest to “View Medical Records,” etc. The head-mounted device may thenbe configured to detect head tilts (e.g., back and forth) to scanthrough different folders, and then to detect an eye blink or head swipeto view the contents of a folder. Other head, eye, and voice gesturesmay be used to interact with medical records in other ways, for example,to view, edit, approve, store, save, update, file, select, etc.

Referring now to FIG. 5, a head-mounted display device for comparing acharacteristic of a medical device with predetermined data for acomponent of the medical device will be described, with reference to anillustrative diagram. In this embodiment, head-mounted display device500 is configured to acquire an image of a component of medical device504 with a camera, to process the image to identify a characteristic ofthe component, to compare the characteristic to predetermined data forthe component, and to generate output data based on the comparison. Theoutput data may be an instruction, alert, warning, verification, screenalert, audible alert, haptic feedback, vibration of device 500, etc. Theoutput data may further trigger or comprise the display of directions ondevice 500 for correcting information (e.g., programming an apheresis orinfusion, etc.). Device 500 may be configured for real time (and/orafter data has been entered or the medical device has been programmed)verification of device programming by imaging data displayed on a screenand comparing it to predetermined database information for properprogramming, such as a doctor's order or prescription.

In one embodiment, a component of the medical device 504 being imaged isa display 511 coupled to the medical device. The image is processed by aprocessing circuit of device 500 to determine data programmed into themedical device by the person, wherein the identified characteristic is aprogrammed value. Indicator 530 shows that a user has programmed themedical device to deliver a medicant to a patient at a rate of 20milliliters per hour. In this case, device 500 acquires an image ofdisplay screen 511 and analyzes the display screen to determine what hasbeen programmed into device 504, e.g., using optical characterrecognition or other image processing techniques. Device 500 thenacquires from a memory 524, such as a prescription database,predetermined data 532, such as prescription data provided by apharmacist, indicating the correct medical prescription for the patient.Device 500 is configured to generate output data indicating whether theprogrammed data meets the medical prescription. The output data can be amessage, display data, a flag stored in memory, or other data. Device500 may be configured to provide at least one of an audible and a visualalert in a case where the programmed data does not meet the medicalprescription. Device 500 may further be configured to display aninstruction 526 to the person for correcting the programmed data. Forexample, instruction 526 instructs the wearer of device 500 to reducethe dosage rate to 10 milliliters per hour, in accordance with theprescription data 532.

In one embodiment, device 500 may be configured at a first time toacquire an image of a written prescription, store the informationregarding the prescription in memory 524 as prescription data 532, andthen later retrieve the prescription data 532 to carry out thecomparison described above.

In another embodiment, device 500 may be configured to monitor and trackuser error corrections, such as when a user erroneously inputs data orinformation and changes the data/information after inputting it. Device500 may use this information to alert specific or general users aboutpotential errors in real-time based on previous errors and/orcorrections made by the specific user or by the general population ofusers that are tracked/monitored. The alerts can be at specific stepsduring data input or can be based on the particular data being enteredin the system.

In another embodiment, the component imaged is a disposable componentconfigured to be loaded into the medical device, such as a blooddonation kit having tubing and a blood bag and optionally a cartridge.In this embodiment, the characteristic of the disposable component is anindication of how the component is loaded into the medical device andwherein the predetermined data is data representing a proper loading ofthe component. For example, device 500 may provide kit loadingverification (e.g., visual identification to ensure proper loading ofkits before a procedure is commenced). For example, one or more codes,marks, or indicators may be printed on the medical device that would becovered by portions of the disposable component (or on the disposablecomponent that would be covered by the medical device) when thecomponent is properly inserted. Device 500 may use its camera to lookfor those marks and, finding none, conclude that the component isproperly installed. Other image processing techniques may be used toidentify proper installation of a disposable kit.

Device 500 may also provide counterfeit kit identification and tracking,with information being sent directly to a server computer of amanufacturer of medical device 504 for further analysis. Device 500 maybe configured to identify aspects of a disposable kit that are presentonly on authorized disposable kits or only non-authorized disposablekits that are observable (e.g., using any type of camera, such asvisible light, infrared, etc. or ultrasound, RFID, or other sensors).The component may be a disposable component (e.g., a blood donation kit,a transfusion bag, cassette, etc.) configured to be loaded into themedical device, wherein the predetermined data is data indicating a typeof disposable component, wherein the comparison indicates whether thedisposable component is of a known type. The type may be a model number,serial number, manufacturer, size, capacity, or other type. Thepredetermined data may represent a type of disposable component approvedfor use with the medical device, such as approved by a manufacturer ofdevice 504, approved by the medical facility, approved by a biomedicalengineer on staff at the medical facility, etc. In this case, the outputdata may comprise a message indicating the disposable component is notapproved for use with the medical device or which has been recalled,which may be displayed on display 526 and/or sent wirelessly to a remotecomputer.

In another embodiment, medical device 504 may be a blood transfusiondevice. A blood transfusion bag may be verified by capturing an image ofthe bag upon removal from a hospital refrigerator, using device 500, andalso verified at the point of transfusion. For example, device 500 maybe programmed to acquire (e.g., automatically, without requiring userinput) an image of the blood transfusion bag when it is in a location inthe vicinity of a previously programmed known location, namely, thelocation of the hospital refrigerator. Device 500 may further use imagerecognition to identify an object in the camera's field of view thatcorresponds to the size, shape, or other distinctive features of a bloodtransfusion bag. The verification may involve matching a patient withthe blood bag ordered to verify blood type, patient identifier, or othercharacteristics. The characteristic may be a code printed on the bloodtransfusion bag, wherein the predetermined data is data associating thecode with a particular patient. The characteristic may alternatively bea date indicative of expiration of blood within the blood transfusionbag, in which device 500 compares the expiration date to the currentdate and provides an alert to the wearer of device 500 if the expirationdate has passed. Bag tagging may occur at the time of blood componentdonation: after blood component collection, labels are placed on theproduct that identify the blood type (O+, A−, etc.). The head-mounteddisplay can be used at the time of blood donation to confirm the labelto the donor. During usage of the blood, at the time of transfusion, thehead-mounted device can check the label on the bag and confirm it is thecorrect blood product and correct blood type prior to transfusing to apatient. A head-mounted device could also be used during an infusion tocheck drug type, dose, concentration, etc. by matching labels.

A head-mounted device may be configured to check for various typematching of the blood component(s) by “scanning” the bag (label or RFIDtag) and comparing it to patient record data retrieved from a databaseand/or patient file.

Prior to some surgeries, a patient will donate some of their bloodcomponents that will then be given back to them during the surgicalprocedures (autologous donation). In this or other situations, thepatient may go to a blood donation center X weeks prior to the surgery,and an autologous collection takes place (component removal would bebased on their specific needs). The blood component collected would belabelled/tagged with the patient's identification. This could be done bystoring the information in a bar code or RFID chip. The identificationwould be a biometric marker, such as a facial profile/feature, voicemapping, retina map, etc. At the time of the surgery, the specific bloodcomponent would be “scanned” by the head-mounted-display and then thepatient would be verified using the HMD using a biometric markercomparison.

In another embodiment, real-time monitoring of activities of theoperator of medical device 504 may be implemented using head-mounteddevice 500. Monitoring may include identification of incorrect input,loading, use, etc. Device 500 may be pinged (by way of a handshake,gate, or other message) by medical device 504 for regular checks of whatdevice 500 sees through one or more cameras or other sensors. Each checkmust be confirmed by the operator before medical device 504 will allowthe operator to proceed to the next step in a process of setting up thedevice, or before medical device 504 will allow a procedure on a patientto begin. The person using device 500 may also acquire images or performchecks at their discretion using a user input device (such as apushbutton, microphone and speech recognition engine responding to avoice command, detected eye movement, etc.). For example, the person maywish to confirm proper loading of the kit, confirm anticoagulant isloaded (vs. saline), etc. at routine intervals during setup orprocedures. Similarly, for an infusion, checks may be made for properdrug, volume, flow rate, bolus size, etc. each time a value isprogrammed, when a new syringe or bag is loaded or connected to thepump, etc.

In another embodiment, medical device 504 may be an infusion pump anddevice 500 may be configured to confirm that the drug name and/or type,volume to be infused, infusion rate, bolus size, etc. have beencorrectly entered in the infusion pump before the infusion pump enablesthe infusion procedure to begin. For example, device 500 may acquire animage of a name of a drug from a label on a drug source (such as a bag,syringe, etc.) holding the drug to be infused. Device 500 may beconfigured to recognize text on the label. Device 500 may then look fora screen of the medical device 504 and monitor inputs provided to thescreen by an operator. When device 500 recognizes that a name of a drughas been selected on the screen, it may compare the name to the namerecognized from the drug source. If the names do not match, an alert maybe provided. If the names do match, either no alert may be provided, ora positive alert message, such as “CORRECT DRUG ENTERED” may bedisplayed on a display of device 500 for viewing by a wearer of device500. A similar check or confirmation may be performed by device 500 eachtime a new syringe or drug is loaded/connected to the pump.

In another embodiment, the head-mounted device may be configured torecognize a drug's concentration, for example by reading a colored labelon bag or syringe of medicament (in a case where a company usesdifferently-colored labels to distinguish concentration) or byrecognizing the specific drug concentration using image processingtechniques such as color matching, optical character recognition, etc.

As mentioned, the image may be acquired by device 500 in response to amessage received from the medical device, for example to verify the bagbefore or after it is installed in the medical device 504. The messagemay be received by direct wireless communication between thehead-mounted display device and the medical device (e.g., without anintervening separate computer) or by communication between a remoteserver computer and the head-mounted display device (e.g., through aplurality of communication networks).

In one embodiment, the processing circuit is configured to receive atleast two messages configured to trigger the acquisition of the image atdifferent times during preparation or operation of the medical device,for example intermittently, or at different stages in programming device504.

In various embodiments, the component of the medical device beingscanned, imaged, or viewed by device 500 may be a display, an inputdevice (e.g., a knob, button, switch, lever, soft key, hard key, etc.),a disposable component used in a medical procedure, a replaceablecomponent, a battery, a mounting mechanism, a tubing, a source of adrug, a blood component receptacle or bag, a cartridge, a door lockinglever or mechanism, a warning or messaging light, or other components ofvarious medical devices. In other embodiments, the component of themedical device being scanned may be a clamp to indicate whether theclamp has been opened or closed by a user, an installation of coloredtubing into the correct colored clamp or colored pump, correct spikingof a bag (e.g., a red spike on a tube matches a red bag of medicament ornutrition source), correct tube in the air detector, using tube size orgeometry of tubing loop, correct tubing placed in a sensor on theinstrument, etc. The head-mounted device could also be configured tocount the number of drops from a solution bag into a drip chamber of atransfer set to ensure the proper flow rate is being achieved (forexample if no pump is used and the clinician is instead doing a gravitydrain).

In various embodiments, the characteristic of the component of themedical device being scanned, imaged or viewed by device 500 may be anytext printed on the component, a color of the component, informationdisplayed by the component, a condition of the component (e.g., is thebag full, empty or partially empty, is the component damaged or inworking condition, is the component packaged or ready to use, is thecomponent tightened or loosened, etc.), a position of the componentrelative to the medical device (e.g., installed or not installed,covering an indicator on a medical device or not covering the indicator,etc.), a setting of the component (e.g., on/off, a value the componentis set at, etc.), or other characteristics of the component.

Referring now to FIG. 6, a head-mounted display device for a patientidentity check will be described, according to an illustrativeembodiment. In this embodiment, a head-mounted display device may beused to verify the identity of a person in a medical facility orclinical setting. The device may be worn by a patient (e.g., blooddonor, surgical patient, etc.) or by a clinician (e.g., doctor, nurse,administrative staff, etc.) and the identity check may be based onfacial recognition and/or saying a person's name at check-in or at thetime of the procedure (e.g., donation, surgery, etc.). The patient couldbe observed by glasses worn by the clinician and/or the patient couldput the glasses on to be identified.

In one embodiment, device 600 is configured to receive at least one ofsound and image data from a sensor (e.g., a microphone configured tosample a voice of the patient, a camera configured to acquire an imageand recognize a face and/or body of the patient, etc.). The sound and/orimage data are associated with a person in the vicinity of the device,such as person 690. Device 600 is configured to compare the sound and/orimage data to sound and/or image data associated with a patient who isto receive the invasive procedure using the medical device, based oninformation from a database 624. Output data is generated based on thecomparison. For example, in a check-in scenario, if the person 690 isrecognized as a patient having a patient record in database 624, theoutput data may trigger an automatic patient check-in process by, forexample, updating the patient's record in database 624 to indicate thepatient has arrived for a medical procedure or is otherwise present.Alternatively, if patient 690 is wearing device 600, device 600 may beconfigured to identify patient 690 and transmit a signal indicative ofthe authentic identification of patient 690 to a computer, such asdevice 600 on person 694's head. The identification of patient 690 mayinclude name, birth date, social security number, home address and/orother identification information stored in memory of the device onperson 690's head and/or stored in another computer, such as proceduredatabase 624. Device 600 may be able to identify patient 690 in any of anumber of ways, such as by scanning a fingerprint of patient 690 at thetime of check-in, scanning a retina of patient 690 at the time ofcheck-in, assessing a unique movement pattern of patient 690, orotherwise sensing and/or authenticating the identity of patient 690.

In another embodiment, a device 600 on patient 690's head may beconfigured to check an identity of person 694, for example using facialor body recognition, voice recognition, etc. This may be useful in thecase where person 690 wishes to confirm that person 694 is an employeeof or otherwise acting under the authority of the medical facility whenperson 694 is asking for personal information of person 690. In thisembodiment, device 600 on patient 690's head may be configured tocommunicate via a wireless network with a database, web page or othernetwork destination to receive confirmation that the person 694 isauthorized to receive personal information from person 690. For purposesof cybersecurity, device 600 and a database networked therewith may beconfigured to verify or ensure credentials of a medical professionalprogramming a medical device and/or the program entered into the medicaldevice. A processing circuit on device 600 may be configured to generateoutput data based on a comparison of input data (e.g., sound data, imagedata, etc.) to data in a database regarding known medical professionals.If the medical professional is known or otherwise authorized to use themedical device, the processing circuit may provide a suitableindication, for example, which may enable the medical device to beprogrammed, a procedure to be started, etc.

In a procedure scenario, the person 690 who checked in may be verifiedby another head-mounted device 692 to confirm the proper patientreceives the proper procedure as stored in procedure database 624. Ahead-mounted display or database 624 may provide an authorization orenabling message to medical device 604 only upon confirmation by suchcomputer that person 690 is the correct patient to receive the medicalprocedure. In another example, the output data may comprise a message tobe displayed on a display. For example, the message on the patient 690'shead-mounted display 698 may state, “Welcome, Mr. Jones. We are readyfor your procedure for a blood donation.” The message on a clinician'shead-mounted display may say, “Mr. Jones is confirmed for a blooddonation. Please direct him to room 101.” Other messages and output dataare contemplated. Patient 690 may be identified by clinician 693'shead-mounted device 692 and/or by patient 690's head-mounted device 698and the identification may occur by facial or body recognition, voicerecognition, retinal scan, and/or other biometric input data.

In a case where person 690 is wearing a head-mounted display device, aforward facing camera may be used, for example, to acquire a retinalscan of person 690 and send the retinal scan data or authentication datato device 600 or database 624 to confirm the identity of person 690.

In one embodiment, device 600 may perform a check-in without requiringuser input, i.e., automatically, upon detection of the person in thevicinity of device 600. The image data may comprise an image of a faceof the person, sound of the person's voice, detection of an RFID tagassociated with the person, an image of a wristband worn by the person,or other detection or identification methods. According to anembodiment, device 600 may automatically configure and/or program adevice based on the location and/or detection of a patient. For example,when used with an apheresis device, device 600 may be configured toprogram or enable a configuration on the apheresis device withpredetermined draw and return flow rates, anticoagulant (e.g., ACD)ratio, etc. by way of a network communication with the apheresis device.Configuration or programming may further comprise an indication of aproduct or products to be collected, e.g., single, double, tripleplatelet with concurrent products such as plasma (with specificvolumes), red cells, etc. Configuration or programming may furthercomprise arm preference (left or right).

As another example, when used with an infusion pump, device 600 may beconfigured to program or enable a configuration on infusion device withpredetermined return flow rate, drug dosing in milligrams (ormilliliters) per minute. Configuration or programming may furthercomprise confirming the correct drug is being used (e.g., with referenceto a prescription stored in a database in communication with device 600and/or the infusion device). Configuration or programming may furthercomprise an indication of arm preference (left or right).

As another example, device 600 may be configured to work with othermedical devices or other computing devices to determine the proper bodyproportions and body mass to pre-program or ensure the correct amount ofanesthesia is set and being delivered. Device 600 may further be used toconfirm the correct side of the patient is being operated on (e.g.,remove the right kidney NOT the left).

In one embodiment, the procedure is compared to patient data stored in adatabase to determine compatibility. For example, a procedure to donateblood may not be compatible with a patient who has patient dataindicating a low blood iron content. As another example, a procedure todonate plasma may not be compatible with a patient below a predeterminedweight. In another example, a procedure to infuse a patient with amedicament may have limited compatibility with a patient, such as amaximum infusion rate based on a person's weight, height, or othercharacteristic.

Referring now to FIG. 7, a head-mounted display device for recordingmedical device information in response to a notification message will bedescribed. In one example, device 700 may be configured to record and/orimage error conditions of medical device 704 and/or report complaints,etc. A processing circuit 703 coupled to frame 701 of device 700 may beconfigured to receive a notification message from medical device 704,for example via communication link 770 (e.g., Wi-Fi, Bluetooth,Ethernet, etc.). The notification message may be merely an instructionto acquire medical device information (e.g., snap a picture, record acode, etc.), which may specify the type of information to acquire (e.g.,video, image, image of specific component, etc.) and which may or maynot be sent in response to an alert, error, caution, warning or alarmcondition of device 704 or as a matter of course in a particularprocedure.

Medical device 704 may be any medical device, such as one configured toperform an invasive procedure on a patient, such as an infusion, anapheresis procedure, a feeding pump operation (enteral or parenteral),etc. Processing circuit 703 may further be configured to record medicaldevice information in response to receiving the notification messagefrom the medical device.

The medical device information may be a video of the medical deviceacquired for a predetermined period of time (e.g., less than 5 seconds,less than 30 seconds, etc.) as seen by camera 708. The medical deviceinformation may comprise at least one error code received from themedical device via the wireless transceiver, via link 770 or anothercommunication link. The error code may identify an error condition ofdevice 704 (e.g., software error, fluid detected in air detector,hemoglobin detector out of range, no saline detected, high pressure inthe line, low plasma detected, weigh scale disturbed, no blood flow,occlusion detected, reservoir overflow, etc.).

The medical device information may comprise an image of a display 711 ofthe medical device. In this example, in response to receiving thenotification, device 700 is configured to determine an error code fromthe image of the display of the medical device (e.g., “error 318”),which may be determined by optical character recognition of an image oftext on screen 711.

Processing circuit 703 may record the medical device information inresponse to receiving the notification message without requiring userinput, for example, automatically. Alternatively, circuit 703 may beginto acquire the medical device information in response to a user input,such as a voice command “begin recording,” pressing a button, shakingdevice 700, or other user input.

FIG. 7A shows example interfaces for blood collection device operatorswho are wearing a head mounted display device. For an operator, anexample application operating on the display device can provideinstrument troubleshooting. For example, the operator can enter an alarmcode or take a picture of the alarm screen or kit configuration of amedical device. The application can present possible solutions; providevideo(s) to resolve issue(s) if needed/desired/configured; use picturerecognition and help access kit setup issues and provide resolutions;link to a hotline; etc.

In certain examples, the application can provide blood productsavailable to be collected based on donor characteristics. Theapplication can communicate how long the collection would take and thenumber of people helped based on the collection, for example. Theapplication can allow for the transfer of procedure information and logfiles from an instrument using a communication protocol/medium such asWi-Fi, Bluetooth, etc. In certain examples, the application cantrigger/push instrument alarms or procedure information to an operator(e.g., receive a text message when an alarm occurs and provide links totroubleshooting if needed/desired/configured). The application canprovide a real time scorecard (e.g., a goal was to collect 15 units withan average turnaround time of 55 minutes). The application can keeptrack of progress and report it back to an administrator, for example.An operator can also see a “scoreboard” on how the operators/teams aredoing, e.g. team competitions. The application can enable the operatorto photograph a label on a product bag and check to help ensure that thebag and donor are correct and that the correct blood type was labeled.

As shown, for example, in FIG. 7A, a computing device 1600, such as asmartphone or other computer, can provide an operator application 1601.The application 1601 can include an alarm troubleshooting interface 1610to assist a device operator in troubleshooting an alarm or errortriggered at a blood collection device, for example. The alarmtroubleshooter 1610 can provide the operator with an option to enter analarm code 1611, such as via a keypad 1620 of a mobile device in thevicinity of the head mounted display. The alarm troubleshooter 1610 canalso provide the operator with an option to capture an alarm code withnumber recognition 1612, such as via a capture screen 1630. The capturescreen 1630 shown in the example of FIG. 7A allows a user to capture,such as using a camera on head-mounted display, an alarm code shown on acollection device 1631. Via the capture interface 1630, the user cancapture 1632, save 1633, and/or delete 1634 a captured image with code1631.

Following input of an alarm code, either through manual entry or photocapture, an alarm troubleshooting guide 1640 is displayed. Thetroubleshooting guide 1640 provides information 1641 including an alarmdefinition for the alarm code along with materials to help the userresolve the alarm. For example, text and/or images to assist theoperator in resolving the device alarm can be provided via the interface1640. The operator can use the interface 1640 to flip between a seriesof pictures/images along with supporting resolution text for eachpicture to resolve the alarm, for example. A help desk option 1642 canbe provided to assist the operator in resolving the alarm, for example.

Selecting the help desk option 1642 brings the operator to a help deskscreen 1650. The help desk screen 1650 provides the user with anopportunity to attach a photograph 1651 of an instrument and/ordisposable set up at issue. The user can also provide information via atext field 1652 regarding the problem. A listing of photos and/or filesattached 1653 can be provided for user confirmation, and the user cansubmit 1654 the information to the help desk. Additionally, an optioncan be provided for the user to call the help desk 1655According toanother embodiment, device 700 may be configured to report a complaint.For example, device 700 may be configured to receive voice commands froma user to move through a menu structure stored in memory and presentedto the user on the display of device 704. The menu structure maycomprise data relating to categories of complaints, malfunctions,errors, troubleshooting tips, etc. For example, a first menu item may be“File a complaint.” Upon selection by the user of the “File a complaint”data element, a “Complaint type” list may be presented to allow a userto select from a plurality of complaint types. For example, a user maychoose “Leak,” in response to which the device presents a list ofcomponents that may have a leak. A user may then select “ACD spike.”Device 700 may then be configured to present a picture or image of thekit with the component highlighted to allow the user to confirm thecomponent selected. Once confirmed, device 700 may be configured totransmit a report (e.g., indicating a failure, defect, etc.) to amanufacturer of the component or internally to a biomedical engineeringdepartment. In addition, any instruction on returning the kit could alsobe provided (e.g., providing mailing address, shipping information,contact information, etc.).

Referring now to FIG. 8, head-mounted display device for determining acharacteristic of blood flowing through a component of a medical devicewill be described. Blood characteristics (e.g., donor hematocrit such asinitial donor hematocrit just prior to the beginning of a medicalprocedure, lipemia, hemolysis, platelet clumping, blood clot,particulate in final product bag, bacterial contamination in finalproduct (post storage), etc.) may be observed, identified and/ormonitored using a camera and image processing algorithms or techniques.For example, donor hematocrit may be determined by visual observationbased on blood characteristics such as color, hue, density, opaqueness,cloudiness, etc. upon the start of a blood donation, wherein bloodbegins flowing through tubing 880, or at various, regular, periodic orintermittent intervals during the procedure. Observation may further bemade of a final separated product present in a bag.

Device 800, while worn by a clinician, may be configured to acquire animage of a component of the medical device, either automatically withoutrequiring user input, or in response to user input. Device 800 may beconfigured to determine a characteristic of blood flowing through thecomponent of the medical device and to generate output data based on thedetermination. The output data may be a visual and/or audiblenotification (e.g., message, alert, alarm, indication, etc.) that theblood characteristic has exceeded a threshold, a textual indication of ameasure of the characteristic, a wireless message sent to a remotecomputing device such as the medical device 804 which may take somefurther action, such as pausing, stopping, or ceasing the medicalprocedure automatically (i.e., without requiring further user input),triggering an alarm on the medical device 804, sending a message over awired or wireless network to a portable electronic device of aclinician, or other actions. This type of data can be tracked, stored inmemory, and/or reported on a display over time in order to storetrending data during a procedure or across multiple procedures. Device800 may be configured to operate a plurality of algorithms on one ormore images of the component containing blood to detect any of a varietyof characteristics (e.g., conditions) of the blood, such as hemolysis,lipemia, icterus, presence of particulate matter, discoloration,bacterial contamination, foreign objects, fibrin strands, etc.

In one example, a grossly lipemic WB/RBC will appear similar to astrawberry milkshake, while a lipemic plasma or platelet component mayhave an opaque or milky appearance.

Device 800 may be configured to make the determination by transmittingat least a portion of an image via a wireless transceiver to a remotecomputer and receiving data indicative of the characteristic of theblood flowing through the component. In this server-based embodiment,more advanced image processing algorithms may be run due to higherprocessing power typically available from a server farm or other servercomputer. A plurality of server computers sharing resources in anetworked environment may be used to process the images. Alternatively,the determination may be made using processing resources on device 800.

The component may be a disposable or non-disposable component of medicaldevice 804. For example, a cartridge, tubing and one or more blood bagsmay be a disposable component for collecting blood from a blood donorusing medical device 804. Device 800 may be configured to image one ormore portions of these elements of a disposable component. A disposablecomponent may be a single-use component intended to be used on a singlepatient and/or for a single procedure and thereafter disposed of.

In another embodiment, device 800 may be configured to analyze images ofblood seen by a clinician during a surgical procedure (e.g., on gauzeused within the body or on a dedicated test strip). In this embodiment,device 800 may be configured to identify blood loss by looking at oracquiring an image of the color of the gauze or other test strip andcomparing the acquired image to predetermined data regarding acharacteristic represented by the color.

In another embodiment, device 800 may be configured to monitor donor orpatient biologics (e.g., pulse or heart rate, eye dilation, temperature,facial flushing, fainting, etc.) during a procedure using a medicaldevice as described herein, during surgery, etc. The monitored biologicscan be reported directly on device 800 or can be compared topredetermined thresholds or other data to determine whether to provide anotification (e.g., message, alert, alarm, etc.) to a user of device 800to bring to the user's attention a condition of the patient or donor.

In another embodiment, a disposable component may be imaged by takingphotos of the kit and bags to determine the amount of fluid that remainsin certain areas and based on the color of the fluid (and an input ofdonor Hct), it could be estimated the amount of red cells within certainareas of the kit.

In another embodiment, device 800 may be configured to assist aclinician in identifying a donor's veins for purposes of either patientidentification (analogous to fingerprinting) or to assist the clinicianin finding a vein for insertion of a needle of a medical device asdescribed herein.

Referring now to FIG. 9, head-mounted display device for interface witha medical device configured to remove blood from a patient will bedescribed. In this embodiment, a blood removal device (e.g., apheresisdevice, transfusion device, blood donation device, etc.) may beconfigured to communicate with a head-mounted display device worn by apatient/donor to indicate to the donor when to squeeze their hand and/orwith how much intensity. The indication may be provided to the donor byway of an audible output from the head-mounted display device (e.g., aspoken command, alarm, etc.), displayed on a display, vibration, and/orother sensory outputs to the patient. In other embodiments, otherindications may be given to a patient or clinician to do certain tasksor take certain actions at predetermined times or conditions during amedical procedure. In another embodiment, the head-mounted displaydevice may be worn by a clinician and audio output may be provided withsuitable volume to instruct the patient/donor and clinician.

FIG. 9 provides examples of indications on a display of a head-mounteddisplay device that may be provided to a donor in the form of donorblood flow indicators 940-946. If no indicator (e.g., no fist) is shown940, then the donor can relax, for example. A first indicator 941 (e.g.,a fist) instructs the donor to lightly squeeze and/or squeeze with lightfrequency. A second indicator 942 (e.g., a fist with one bar) instructsthe donor to squeeze normally and/or with a normal frequency. A thirdindicator 943 (e.g., a fist with two bars) instructs the donor tosqueeze hard and/or with more frequency. In certain examples, a color ofthe indicator (e.g., blue or red) can change to indicate a state ofblood flow, collection progress and/or degree of squeezing needed. Forexample, a blue fist and/or bars 941-943 can change to a red fist and/orbars in indicators 944-945. In certain examples, the indicator can flashto instruct the donor regarding the frequency of squeeze. A completionindicator 946 appears when the blood collection process has beencompleted.

A processing circuit of the head-mounted device may be configured toreceive an instruction from the medical device, the instruction relatingto removal of blood from the patient (e.g., squeeze intensity, procedurecompleted, volume collected, target volume, etc.). The processingcircuit may be configured to provide an indication of the instruction toat least one of the display and another output circuit for the patient.Other output circuits may comprise a vibration device or other hapticfeedback device, a sound transducer (e.g., a speaker or a soundtransducer coupled to a headphone interface circuit), etc. For example,increase in haptic feedback (i.e. vibrations) could be made to indicateto the donor that more/harder squeezes are required. Further, hapticfeedback could be made to a head-mounted device worn by an operator ofthe device to let them know that there is an issue with thedonor/instrument.

The head-mounted display device may receive the instruction message(e.g., a bit, flag, data message, etc.) directly from the medical devicevia a local wireless network (e.g., a Bluetooth network, Wi-Fi, Zigbee,short-range wireless network, personal area network, etc.).Alternatively, the head-mounted display device may receive theinstruction from a remote computer in communication with the network,the remote computer receiving the signal from the medical device over asecond network (e.g., Ethernet).

In another embodiment, the head-mounted display device worn by thepatient may be configured to receive voice commands from thedonor/patient that can be interpreted and acted on. For example, thepatient/donor may audibly state that help is needed or that they do notunderstand the instructions. The head-mounted display device may beconfigured to interpret the command and take an action, such as alertinga nearby clinician by way of a wireless message (e.g., text message,pager message, etc.) that assistance is needed and/or an indication(e.g., volume, number of vibrations, etc.) of the severity, urgency orimportance of the request for assistance.

In another embodiment, the head-mounted display (or heads-up display orHUD) could also be used to assess eye pupil feedback (change in shape oreye movement), which could be indicative of the donor's/patient's changein emotional state, i.e. scared, confused, etc. A similar techniquecould be made on an operator (of, for example, apheresis or infusionpumps) to assess their confidence in the setting up or changing of aprocedure parameter. Based on this assessment the instrument couldprovide additional confirmations or help options to minimize operatorerror. Additionally, if the parameters were set at a very high end, i.e.a potential dangerous dose to a patient, and the operator seems to be inan inappropriate state, the HUD could keep the change from beingimplemented or could inform a supervisor by way of an electronicmessage, alert, etc.

In another embodiment, the head-mounted display device worn by thepatient may be configured to display entertainment such as videos,movies, games, etc. for the patient during the process. Wheninstructions are needed, such as to indicate desired squeeze frequencyand/or intensity or to indicate the procedure is complete, theinstruction messages may be displayed as an overlay over part of theentertainment being displayed. Entertainment may be streamed from aremote source, or played from a local memory on head-mounted displaydevice. In one example, a calming scene may be played along with calmingmusic to reduce patient/donor anxiety during the medical procedure. Inone embodiment, head-mounted display may comprise a virtual realityengine configured to provide video, audio and/or other sensory stimulito give the wearer a simulated physical presence in places in the realworld or imagined worlds.

In one embodiment, the information and/or instruction is derived fromcollected sensor data regarding donor vein and blood pressure feedback,collected volume at the system, weight scale readings of a collectionbag, pressure sensors within the apheresis device, etc.

In another embodiment, the indication to the patient/donor may comprisea target collection volume for the donor, which may be a valueprogrammed into the blood collection system by the operator for thedonor. The volume collected so far and target collection volume for thedonor may be both displayed in the same numerical units.

Referring now to FIG. 10, a head-mounted display device for authorizinga feature based on visual cues will be described, according to anillustrative embodiment. For example, if the head-mounted display devicesees genuine inventory or a certain number of inventory/kits, the devicewill authorize the medical device 1004 to perform a step.

One feature that may be improved with an authorization feature issterile docking. Sterile docking may refer to a process in which twotubes are joined together in a sterile manner using heat. Apheresismachine 1004 comprises an integrated dock station 1070 on the machineconfigured to join together two tubes using heat. If an operator ofmachine 1004 lines up a docking kit 1072 to a kit 1074 already loaded onthe device 1004 in the docking station 1070, device 1000 may detect thisevent using camera 1008 and an image processing algorithm thatcontinually compares what is seen or imaged by camera 1008 topredetermined known patterns stored in memory. A processing circuit ofdevice 1000 is configured to acquire an image of docking station 1070 ofmedical device 1000 with camera 1008, to process the image to identifythe presence of two tubes lined up for a sterile docking (e.g., in thevicinity of each other and/or docking station 1070) and to determinewhether docking station 1070 and/or the kits 1072, 1074 are authorizedfor this use. For example, a manufacturer of device 1004 may have alimit on the number of times docking station 1070 may be used, forexample in a period of time or depending on the number of kitspurchased. Device 1000 may be configured to enable docking station 1070(by a wireless message to a processing circuit within medical device1004) if there are remaining “docks” left (as determined by reference toa number of docks left stored in device 1004, device 1000 or in a remotecomputer. In one example, the number of docks remaining is stored in adatabase on device 1004 or in another computer in communication withdevice 1004, and a plurality of head-mounted devices 1000 may eachreport to the database whenever a docking is detected.

This embodiment may be applied to other components or features of device1004 and device 1000 may detect other characteristics of device 1004 orcomponents thereof to make the determination as to whether their use isauthorized. For example, device 1000 may acquire an image of adisposable component held in front of device 1004 to determine whetherthe component is compatible with device 1000. The disposable componentmay be identified using any of a number of technologies, such as a QRcode, an RFID tag, image recognition of a portion of the disposablecomponent, etc. Device 1000 may then send the identification of thedisposable component to a remote database or local memory of componentsto determine whether the component is authorized. A secure message maythen be transmitted by device 1000 to device 1004 to authorize or notauthorize a procedure to be carried out using device 1004.

In one embodiment, a medical device 1004 may be authorized to onlyoperate with a disposable component that meets certain compatibilitycriteria. In this case, head-mounted device 1000 may be configured todetect with its camera whether the disposable component meets thecompatibility criteria, for example by looking for a particular featureor aspect of the kit, by looking for or otherwise detecting anidentifier code associated with the kit, etc. In another embodiment,medical device 1004 may only be authorized to operate with apredetermined number of disposable components. In this case, one or morehead-mounted devices 1000 may be configured to count a number of timesmedical device 1004 is used with a different disposable component andstore this information in a database local to device 1000 or remotethereto. When a limit has been reached, a computer in communication withthe database may send a message to medical device 1004 and/orhead-mounted device 1000 (which may then forward the message to medicaldevice 1004) indicating the limit has been reached, disabling furtheruse of medical device 1004, providing information about how more usesmay be obtained, etc.

In various embodiments, head-mounted device 1000 may be configured tocontinually monitor images from its camera to detect a known condition,based on comparison to prestored image characteristics. Alternatively,monitoring may be initiated or activated by user input. In anotherembodiment, monitoring may be activated by a determination by device1000 or device 1004 that the devices are in proximity of each other, forexample using near-field communication, a Bluetooth communication, aninfrared signal, a motion detector, or other sensors on device 1000and/or device 1004.

In another embodiment, a head-mounted device could be used to authorizea user to use a medical device or instrument. For example, a camera onthe head-mounted device may be configured to acquire a biometricindicator of a person wearing the camera, such as an image of a person'shand or finger, a retinal scan from a user-facing camera, a sample of aperson's voice authenticated by a voice recognition algorithm operatingon the head-mounted device, etc. The head-mounted device and/or medicaldevice may be configured to determine whether the user is authorized touse the medical device and, optionally, may also be configured todetermine what features or functions of the medical device the person isauthorized to use, selected from a group of features or functions.

In another embodiment, after a user has used the medical device, themedical device may be configured to determine that communication withthe head-mounted device has been lost, or the head-mounted device isotherwise no longer present or in the vicinity of the medical device(for example, using a near-field communication device, personal areanetwork, or other technology). In any of these cases, the medical devicemay be configured to lock down the instrument (e.g., using an NFChandshake), for example by preventing access to one or more or all ofthe features or functions of the medical device. For example, themedical device may be configured to lock a setting of the device so thatthe setting cannot be changed after the user has left the vicinity ofthe device by other users. Optionally, the medical device may beconfigured to lock a setting of the device so that the setting cannot bechanged after the user has left the vicinity of the device by otherusers unless the other user is on a list of authorized users stored inmemory. The list of authorized users may comprise multiple levels ofaccess for different types of users, such as User Type A may access andchange all features or settings, User Type B may access or change onlysettings X and Y, and User Type C may not access or change any settings.For example, on an infusion pump only certain authorized users couldchange a flow rate setting.

In another embodiment, the medical device may be configured to use anNFC or other communication device in communication with the head-mounteddisplay to record in a database information about a user's interactionwith the medical device. For example, the medical device could be usedto track the user, and when and what settings were changed on themedical device when that user was present. A list of users and theirrespective setting changes may be kept in the medical device for laterretrieval and analysis for such tasks as training, improvement in caredelivery, evaluation, and error analysis.

Additional Embodiments

According to another embodiment, a head-mounted display such as thatdescribed herein may be used for data input to apheresis and bloodcomponent processing devices, enteral/parenteral pumps, and infusiondevices. The data input may be human eye-controlled data input and/orprogramming of medical devices or data input to databases.

According to another embodiment, a head-mounted display such as thatdescribed herein may be used for motion controlled data input and/orprogramming (to devices, from devices, to database, from database,etc.).

According to another embodiment, a head-mounted display may be used forvisual and/or haptic feedback for data transfer and procedures fromother devices to a person wearing the head-mounted display.

According to another embodiment, real time instrument status,notifications, and/or alarms may be displayed and/or haptic feedback maybe provided to a head-mounted display based upon actual user location(e.g., if a user is in a room or within a predetermined distance of themedical device) and/or on demand (e.g., in response to a request fromthe user for such information).

According to another embodiment, a head-mounted display device such asthat described herein may be configured to perform scheduling (e.g.,appointments, blood donations, medical procedures, etc.), which may bedisplayed in real time and/or upon operator request. For example, anintake clinician may speak information received from a patient into amicrophone of a head-mounted display device to populate a patientrecord, search for an schedule an appointment, check-in the patient forthe appointment, schedule a follow-up appointment, etc.

According to another embodiment, a barcode reader may be implemented bya processing circuit of a head-mounted display device for kit and/orblood product tracking, identification, and data entry into machines anddevices.

According to another embodiment, a photo application may be implementedon a head-mounted display device for onscreen product identification,device ID, inventory control, tracking, etc.

According to another embodiment, real time updates may be provided todonor, device, center, medical records, etc. enabled with voice and/orphoto updates to or from a head-mounted display device.

The devices described herein can make any of the determinations,comparisons, calculations, analyses, etc. described locally and/or bysending a request to a server to do the processing.

A head-mounted display device for use in a medical facility may comprisea frame configured to be mounted on a person's head, wherein the personhas a view of the medical facility relative to the frame; a display; awireless transceiver configured to communicate with a network; and aprocessing circuit coupled to the frame, the display and the wirelesstransceiver, wherein the processing circuit is configured to receiveinformation regarding a location of a medical product or patient via thewireless transceiver, to provide a visual indication of the location onthe display, to detect a change in the view of the person and to changethe visual indication of the location on the display in response to thedetected change in view. The medical facility may be a blood donationfacility, wherein the medical product comprises a blood donation kit.The patient may be a blood donor. The visual indication of the locationmay comprise a graphical representation in the person's view of themedical facility through the frame. The display may comprise a displaysurface configured to reflect projected images representing the visuallocation and to allow the person to see through the display surface. Thevisual indication may comprise a graphical or textual description of thelocation comprising at least one of a distance and a physicaldescription. The location may be received from a remote databasecomprising location data for a plurality of different medical productsor different patients. The processing circuit may be configured todetect the change in view of the person based on at least one of anaccelerometer and a gyroscope. The processing circuit may be configuredto detect the change in view of the person based on a calculatedphysical location of the device. The location may be generated by theprocessing circuit based on signals received from the wirelesstransceiver. The location may be generated using a near fieldcommunication technology. The location may be a location relative to thedevice. The processing circuit may be configured to receive an inventorydata representing a number of the medical product in inventory, theprocessing circuit configured to display the inventory data on thedisplay. The displayed inventory data may be displayed in the person'sview of the medical facility through the frame in a screen locationrelated to a location of the medical product in the person's view. Theprocessing circuit may be further configured to receive at least one ofinformation regarding a quantity, manufacturer and expiration data forthe medical product. The medical product may be for use in an infusionor feeding operation.

A system for use in a medical facility may comprise a blood treatmentmachine operable with a disposable medical product; a frame configuredto be mounted on a person's head, wherein the person has a view of themedical facility relative to the frame; a display; a wirelesstransceiver configured to communicate with a network; and a processingcircuit coupled to the frame, the display and the wireless transceiver,wherein the processing circuit is configured to receive informationregarding a location of the disposable medical product via the wirelesstransceiver, to provide a visual indication of the location on thedisplay, to detect a change in the view of the person and to change thevisual indication of the location on the display in response to thedetected change in view. The blood treatment machine may comprise anapheresis machine.

A head-mounted display device for use in a medical facility may comprisea frame configured to be mounted on a person's head, wherein the personhas a view of the medical facility relative to the frame; a display; awireless transceiver configured to communicate with a network; and aprocessing circuit coupled to the frame, the display and the wirelesstransceiver, wherein the processing circuit is configured to receiveinformation regarding a location of a medical product or patient via thewireless transceiver, to provide a visual indication of the location onthe display, wherein the visual indication comprises an identifier ofthe medical product or patient and a physical description of thelocation of the medical product or patient, to detect a change in theview of the person and to change the visual indication of the locationon the display in response to the detected change in view. The physicaldescription may be at least one of a room number and a compartmentidentifier.

A head-mounted display device for interface with a medical deviceconfigured to perform an invasive procedure on a patient may comprise: aframe configured to be mounted on a person's head; a display; a camera;a wireless transceiver configured to communicate with a network; and aprocessing circuit coupled to the frame, the display, the camera and thewireless transceiver, wherein the processing circuit is configured toacquire an image of a component of the medical device with the camera,to process the image to identify a characteristic of the component, tocompare the characteristic to predetermined data for the component, andto generate output data based on the comparison. The component may be adisplay of the medical device. The image may be processed to determinedata programmed into the medical device by the person, wherein theidentified characteristic is a programmed value. The predetermined datamay be a medical prescription and the output data is an indication as towhether the programmed data meets the medical prescription. The devicemay be configured to provide at least one of an audible alert and avisual alert in a case where the programmed data does not meet themedical prescription. In a case where the programmed data does not meetthe medical prescription, the device may be configured to display aninstruction to the person for correcting the programmed data. Themedical device may be an apheresis device or an infusion device or apatient feeding device. The processing circuit may be configured togenerate the predetermined data for the component based on an imageacquired by the camera. The component may be a disposable componentconfigured to be loaded into the medical device, wherein thecharacteristic of the disposable component is an indication of how thecomponent is loaded into the medical device and wherein thepredetermined data is data representing a proper loading of thecomponent. The component may be a disposable component configured to beloaded into the medical device, wherein the predetermined data is dataindicating a type of disposable component, wherein the comparisonindicates whether the disposable component is of a known type. Thepredetermined data may represent a type of disposable component approvedfor use with the medical device. The output data may comprise a messageindicating the disposable component is not approved for use with themedical device. The processing circuit may be configured to send amessage wirelessly to a remote computer indicating the disposablecomponent is not approved for use with the medical device. The medicaldevice may be a transfusion apparatus, wherein the component is a bloodtransfusion bag. The characteristic may be a code printed on the bloodtransfusion bag, wherein the predetermined data is data associating thecode with a particular patient. The characteristic may be a dateindicative of expiration of blood within the blood transfusion bag. Theprocessing circuit may be configured to acquire the image in response toa message received from the medical device. The message may be receivedby direct wireless communication between the head-mounted display deviceand the medical device or by communication between a remote servercomputer and the head-mounted display device. The processing circuit maybe configured to receive at least two messages configured to trigger theacquisition of the image at different times during preparation oroperation of the medical device. The device may be configured to detecta proper loading of a disposable component and to confirm the loading ofan anticoagulant. The device may be configured to detect a properprogramming of the medical device according to a medical prescriptionand to confirm a drug source is loaded into the medical device. Theprocessing circuit may be configured to acquire the image in response touser input from the person wearing the head-mounted display. The userinput may be received from a microphone or button.

A system may comprise a medical device configured to perform an invasiveprocedure on a patient; a frame configured to be mounted on a person'shead; a display; a camera; a wireless transceiver configured tocommunicate with a network; and a processing circuit coupled to theframe, the display, the camera and the wireless transceiver, wherein theprocessing circuit is configured to acquire an image of a component ofthe medical device with the camera, to process the image to identify acharacteristic of the component, to compare the characteristic topredetermined data for the component, and to generate output data basedon the comparison. The medical device may be an apheresis device or aninfusion device or a patient feeding device.

A head-mounted display device for interface with a medical deviceconfigured to perform an invasive procedure on a patient may comprise aframe configured to be mounted on a person's head; a display; a sensor;a wireless transceiver configured to communicate with a network; and aprocessing circuit coupled to the frame, the display, the sensor and thewireless transceiver, wherein the processing circuit is configured toreceive at least one of sound and image data from the sensor, whereinthe at least one of sound and image data is associated with a person inthe vicinity of the device, to compare the at least one of sound andimage data to the at least one of sound and image data associated withthe patient who is to receive the invasive procedure using the medicaldevice, and to generate output data based on the comparison. The sounddata may comprise a sample of a voice of the person in the vicinity ofthe device. The processing circuit may be configured to use voicerecognition to do the comparison. The image data may comprise an imageof the person in the vicinity of the device. The processing circuit maybe configured to use facial recognition to do the comparison. The devicemay be configured to acquire the image of the person in the vicinity ofthe device while the person in the vicinity of the device is wearing thedevice. The processing circuit may be configured to use a retinal scanto do the comparison. Both sound and image data associated with theperson in the vicinity of the device may be compared to sound and imagedata associated with the patient who is to receive the invasiveprocedure using the medical device. The output data may comprise amessage to be displayed on the display. The output data may comprise acommand to the medical device to allow the procedure. The medical devicemay be a blood donation apparatus and the output data comprises acheck-in message to check the patient in for a blood donation procedure.The processing circuit may perform the check-in without requiring userinput. The image data may comprise an image of a wristband worn by theperson in the vicinity of the device. The image data may comprise animage of a bar code associated with the person in the vicinity of thedevice. The sensor may comprise an RFID sensor configured to identify anRFID tag or transmitter worn by the person in the vicinity of thedevice. The procedure may be compared to patient data stored in adatabase to determine compatibility.

A head-mounted display device for interface with a medical deviceconfigured to perform an invasive procedure on a patient may comprise aframe configured to be mounted on a person's head; a display; a sensor;a wireless transceiver configured to communicate with a network; and aprocessing circuit coupled to the frame, the display, the sensor and thewireless transceiver, wherein the processing circuit is configured toreceive at least one of sound and image data from the sensor, whereinthe at least one of sound and image data is associated with a person inthe vicinity of the device, to compare the at least one of sound andimage data to the at least one of sound and image data associated withthe patient who is to receive the invasive procedure using the medicaldevice, and to generate output data based on the comparison, wherein theoutput data comprises a programming message configured to program anoperational characteristic of the medical device configured to performan invasive procedure on a patient. The programming message may beconfigured to program a blood product donation operation on the medicaldevice.

A head-mounted display device for interface with a medical deviceconfigured to perform an invasive procedure on a patient may comprise aframe configured to be mounted on a person's head; a display; a sensor;a wireless transceiver configured to communicate with a network; and aprocessing circuit coupled to the frame, the display, the sensor and thewireless transceiver, wherein the processing circuit is configured toreceive at least one of sound and image data associated with a person inthe vicinity of the device, to compare the at least one of sound andimage data to at least one of sound and image data associated with amedical professional who is to use the medical device and to generateoutput data based on the comparison, wherein the output data comprisesan indication that the medical professional is approved to use themedical device.

A head-mounted display device for interface with a medical deviceconfigured to perform an invasive procedure on a patient may comprise aframe configured to be mounted on a person's head; a display; a wirelesstransceiver configured to communicate with a network; and a processingcircuit coupled to the frame, the display and the wireless transceiver,wherein the processing circuit is configured to receive a notificationmessage from the medical device, the medical device being configured toperform an invasive procedure on a patient, the processing circuitfurther configured to record medical device information in response toreceiving the notification message from the medical device. The devicemay comprise a camera, wherein the medical device information is videoof the medical device as seen by the camera. The medical deviceinformation may comprise at least one error code received from themedical device via the wireless transceiver. The device may comprise acamera, wherein the medical device information is an image of a displayof the medical device. The device may be configured to determine anerror code from the image of the display of the medical device. Theprocessing circuit may record the medical device information in responseto receiving the notification message without requiring user input. Themedical device may be an infusion pump and the notification message isreceived in response to an occlusion in a line detected by the infusionpump. The medical device may be an apheresis machine. The medical devicemay be a feeding pump.

A head-mounted display device for interface with a medical deviceconfigured to perform an invasive procedure on a patient may comprise aframe configured to be mounted on a person's head; a display; a wirelesstransceiver configured to communicate with a network; and a processingcircuit coupled to the frame, the display and the wireless transceiver,wherein the processing circuit is configured to receive an input signal,the processing circuit further configured to record medical deviceinformation in response to receiving the input signal, the processingcircuit configured to display a response message on the display based onthe recorded medical device information. The response message maycomprise a confirmation message that the recorded medical deviceinformation has been recorded or received by a remote computer. Theinput signal may be received from a user input device. The processingcircuit may be configured to automatically record the medical deviceinformation in response to receiving the input signal. The processingcircuit may be configured to await a user input before recording themedical device information after receiving the input signal. The inputsignal may be received from the medical device. The input signal maycomprise data regarding an error condition of the medical device. Themedical device information may comprise an image of a disposable unitinstalled on the medical device.

A system for performing an invasive procedure on a patient may comprisea medical device configured to perform an invasive procedure on apatient; a head-mounted display device for interface with the medicaldevice. The head-mounted display device may comprise a frame configuredto be mounted on a person's head; a display; a wireless transceiverconfigured to communicate with a network; and a processing circuitcoupled to the frame, the display and the wireless transceiver, whereinthe processing circuit is configured to receive a notification messagefrom the medical device, the medical device being configured to performan invasive procedure on a patient, the processing circuit furtherconfigured to record medical device information in response to receivingthe notification message from the medical device. The medical device maycomprise an infusion pump, an enteral feeding pump or a blood processingdevice. The processing circuit may further be configured to receive acomment from a person about the operation of the medical device and totransmit the comment to a remote computer via the wireless transceiver.

A head-mounted display device for interface with a medical deviceconfigured to perform an invasive procedure on a patient may comprise aframe configured to be mounted on a person's head; a display; a camera;a wireless transceiver configured to communicate with a network; and aprocessing circuit coupled to the frame, the display, the camera and thewireless transceiver, wherein the processing circuit is configured toacquire an image of a component of the medical device, the medicaldevice being configured to perform an invasive procedure on a patient,the processing circuit further configured to determine a characteristicof blood flowing through the component of the medical device and togenerate output data based on the determination. The processing circuitmay be configured to make the determination by transmitting at least aportion of the image via the wireless transceiver to a remote computerand receiving data indicative of the characteristic of the blood flowingthrough the component. The characteristic may be a hematocrit level ofthe blood. The component may be tubing. The component may be configuredfor use on a single patient. The processing circuit may be furtherconfigured to acquire additional images of the component at differenttimes, to determine the characteristic of blood flowing through thecomponent at the different times, and to store the determinedcharacteristics in a memory device. The additional images may beacquired without requiring user input. The medical device may be anapheresis machine. The component may be a disposable component.

A head-mounted display device for interface with a medical deviceconfigured to perform an invasive procedure on a patient may comprise aframe configured to be mounted on a person's head; a display; a camera;a wireless transceiver configured to communicate with a network; and aprocessing circuit coupled to the frame, the display, the camera and thewireless transceiver, wherein the processing circuit is configured toimage a disposable component of the medical device, the medical devicebeing configured to perform an invasive procedure on a patient, theprocessing circuit further configured to determine a characteristic ofblood in the disposable component of the medical device, to compare thecharacteristic to a predetermined threshold, and to generate anotification based on the comparison. The characteristic may be a bloodhematocrit. The medical device may be an apheresis device. Thedisposable component may comprise a tube and a bag. The notification maycomprise a signal to the medical device that a donation procedure maybegin. The processing circuit may be configured to control the camera toacquire a plurality of images over time, determine a blood hematocritfor each image, and store the plurality of blood hematocrits in a filein a memory device.

A system for performing an apheresis procedure on a patient may comprisean apheresis medical device; a head-mounted display device comprising aframe configured to be mounted on a person's head, a display, a camera,a wireless transceiver configured to communicate with a communicationnetwork, and a processing circuit coupled to the frame, the display, thecamera and the wireless transceiver, wherein the processing circuit isconfigured to acquire an image of a component of the apheresis medicaldevice, the processing circuit further configured to determine acharacteristic of blood flowing through the component of the medicaldevice and to generate output data based on the determination. Theprocessing circuit may be configured to transmit a signal based on theoutput data to the apheresis medical device. The apheresis medicaldevice may be configured to stop an apheresis procedure based on thesignal received from the processing circuit of the head-mounted displaydevice. The processing circuit may be configured to make thedetermination by transmitting at least a portion of the image via thewireless transceiver to a remote computer and receiving data indicativeof the characteristic of the blood flowing through the component. Thecomponent may be tubing.

A head-mounted display device for interface with a medical deviceconfigured to remove blood from a patient may comprise a frameconfigured to be mounted on the patient's head; a display; a wirelesstransceiver configured to communicate with a network; and a processingcircuit coupled to the frame, the display and the wireless transceiver,wherein the processing circuit is configured to receive an instructionfrom the medical device, the instruction relating to removal of bloodfrom the patient, the processing circuit further configured to providean indication of the instruction to at least one of the display andanother output circuit for the patient. The processing circuit mayreceive the instruction directly from the medical device via a localwireless network. The processing circuit may receive the instructionfrom a remote computer in communication with the network, the remotecomputer receiving the signal from the medical device over a secondnetwork. The indication may instruct the patient to squeeze a hand. Theindication may comprise an icon of a fist. The indication may comprisetext. The indication may further indicate an intensity with which thepatient is to squeeze the hand. The another output circuit may comprisea vibration device. The another output circuit may comprise a soundtransducer. The sound transducer may be coupled to a headphone interfacecircuit.

A head-mounted display device for interface with a medical deviceconfigured to remove blood from a patient may comprise a frameconfigured to be mounted on the patient's head; a display; a wirelesstransceiver configured to communicate with a network; and a processingcircuit coupled to the frame, the display and the wireless transceiver,wherein the processing circuit is configured to receive an instructionfrom the medical device, the processing circuit further configured toprovide an indication of the instruction the display, wherein theindication indicates an intensity with which the patient is to squeeze ahand. The indication may comprise an icon of a fist. The display devicemay further comprise a vibration device configured to vibrate inresponse to the instruction from the medical device.

A system for removing plasma from a donor may comprise a plasmapheresisdevice configured to separate plasma from red blood cells and return thered blood cells to the donor; and a head-mounted display device forinterface with the plasmapheresis device. The head-mounted displaydevice may comprise a frame configured to be mounted on the donor'shead; a display; a wireless transceiver configured to communicate withthe plasmapheresis device; and a processing circuit coupled to theframe, the display and the wireless transceiver, wherein the processingcircuit is configured to receive a message from the plasmapheresisdevice, the message relating to a plasmapheresis procedure beingperformed on the donor, the processing circuit further configured toprovide an indication of the instruction to the display for the donor tosee. The indication may instruct the patient to squeeze a hand. Theindication may comprise an icon of a fist. The indication may comprisetext. The indication may further indicate an intensity with which thepatient is to squeeze the hand. The plasmapheresis device may beconfigured to derive the instruction from a sensor on the plasmapheresisdevice. The plasmapheresis device may be configured to detect a low flowcondition based on signals from the sensor and to generate the messageto the head-mounted display device in response to the low flowcondition.

A head-mounted display device for interface with a medical deviceconfigured to perform an invasive procedure on a patient may comprise aframe configured to be mounted on a person's head; a display; a camera;a wireless transceiver configured to communicate with a network; and aprocessing circuit coupled to the frame, the display, the camera and thewireless transceiver, wherein the processing circuit is configured toacquire an image of a component of the medical device with the camera,to process the image to identify a characteristic of the component, todetermine whether the component is authorized for use, and to transmit amessage to the medical device based on whether the component isauthorized for use. The medical device may be an apheresis machine andthe component may be a dock station. The characteristic of the componentmay be whether a disposable component is in the vicinity of thecomponent. The characteristic of the component may be whether adisposable component is aligned with another disposable componentinstalled on the device. The message may cause the device to enable thecomponent for use. The determination may be made by checking a databasefor a number of uses of the component for the particular medical device.

A head-mounted display device for interface with a medical deviceconfigured to perform an invasive procedure on a patient may comprise aframe configured to be mounted on a person's head; a display; a camera;a wireless transceiver; and a processing circuit coupled to the frame,the display, the camera and the wireless transceiver, wherein theprocessing circuit is configured to acquire an image of the medicaldevice with the camera, to process the image to identify acharacteristic of the medical device, to determine whether the medicaldevice is authorized for use, and to transmit a message based on whetherthe medical device is authorized for use. The medical device may be anapheresis machine. The characteristic of the medical device may be anumber of times the medical device has been used in a predeterminedmanner. The message may cause the device to enable a single-usedisposable component for use. The determination may be made by checkinga database for a number of uses of the component for the particularmedical device.

A system for performing an invasive procedure on a person may comprise amedical device configured to perform an invasive procedure on a personand a head-mounted display device for interface with the medical device.The head-mounted display device may comprise a frame configured to bemounted on a person's head; a display; a camera; a wireless transceiver;and a processing circuit coupled to the frame, the display, the cameraand the wireless transceiver, wherein the processing circuit isconfigured to acquire an image of a component of the medical device withthe camera, to process the image to identify a characteristic of thecomponent, to determine whether the component is authorized for use, andto transmit a message to the medical device based on whether thecomponent is authorized for use. The medical device may be an apheresismachine and the component is a dock station integral with the medicaldevice. The characteristic of the component may be whether a disposablecomponent is in the vicinity of the component. The characteristic of thecomponent may be whether a disposable component is aligned with anotherdisposable component installed on the device. The message may cause thedevice to enable the component for use. The determination may be made bychecking a database for a number of uses of the component for theparticular medical device. The component may be a disposable, single-usecomponent. The component may comprise a tube configured to pass bloodproducts therethrough. Authorization may be determined by reference todata in a database.

Referring now to FIG. 11, a method of recording a state of an apheresismachine having a disposable component disposed thereon will bedescribed. As described herein, some medical devices, such as apheresismachines, may use a disposable component which is installed on theapheresis device by a human operator and is intended to be disposed ofafter use for a single procedure or multiple procedures for a singlepatient. In some embodiments, the state of the apheresis machine can berecorded by visual image to show whether the machine is in a statehaving a properly installed disposable component or is in a state ofhaving an improperly installed disposable component. Other states of themachine or aspects of the machine's state can be recorded, such asalarms or alerts displayed on the display, the display screen beingshown at the time, the presence or absence of one or more fluids in thelines and/or bags of the disposable component, etc.

At block 1100, the medical device is configured to detect an errorcondition on the apheresis device. The error condition can be detectedby a programmed processing circuit (e.g., microprocessor,microcontroller, control circuit, application-specific integratedcircuit, or other compilation of analog and/or digital circuitcomponents, etc.) running an operating algorithm or program whichcontinuously, periodically, or intermittently monitors certain inputsfrom the machine, such as sensors, detectors, motor currents, userinputs, etc. The error condition may be a significant alarm issue thatthe instrument detected, particularly in a situation of an adverseevent. In one example, the significant alarm issue may be the detectionof red blood cells at a plasma line hemoglobin sensor leading to aplasma collection. In another example, the significant alarm issue maybe fluid detection on a pressure transducer. In another example, thesignificant alarm issue may be blood leak detection on the disposablecomponent. In response to the detection of the error condition, theprocessing circuit of the medical device may be configured (at block1102) to provide at least one of an audible alert and a visual alert tothe human operator. The processing circuit may also be configured (atblock 1104) to acquire with a camera an image of a portion of theapheresis machine having the disposable component. The image may beacquired automatically without requiring user input. In alternativeembodiments, the user may be prompted to request the device acquire animage by way of pressing a user input device (e.g., a button on a touchscreen, a hard key, a softkey, a voice command, etc.). In someembodiments, the detection of the error condition sets into motion theacquisition and recording of the image without requiring or promptingfor any manual user input.

At block 1106, certain medical device information may be stored, such asthe image, a device identifier, status information about the device(e.g., whether it was running or idle, the particulars of user inputs,the step or stage in a collection process, etc.), make, model or type ofmedical device, etc. At a block 1108, the processing circuit may beconfigured to generate a message in a communication format and (at block1110), the message may be transmitted over a network to a computerremote from the medical device (e.g., in another room of a facility, inanother building of a campus, or in another city, state, country, etc.).The storage, generating and transmission may occur automatically, inresponse to the triggering event of the error condition being detected.Alternatively, one or more of the steps may require user input orconfirmation in alternate embodiments before the step is executed.

FIG. 13 provides an illustration of an apheresis machine 110 having adisposable component 114, according to an exemplary embodiment. As canbe seen, disposable component 114 comprises a plurality of lines ortubes interconnecting several bags 120. Bags may be provided as a sourceof anticoagulant, saline or other additives. Bags may be alternativelybe provided to collect blood components, such as plasma, red bloodcells, white blood cells, etc.

A human operator is tasked with loading the apheresis machine 110 withthe disposable component 114 and aligning the tubes or lines with pumps,sensors, channels, and other components of the apheresis machine. It ispossible that the human operator improperly installs the disposablecomponent, which can lead to error conditions during operation of themachine. When diagnosing the cause of an error condition (e.g., redplasma, noise, brown urine, etc.), it is difficult to investigate theroot cause without information about the state of the machine and itsdisposable component. Further, if the disposable component is removed,the arrangement has been disturbed which also may make it difficult toidentify the cause of the error.

As shown, a camera or camera sensor is coupled to a portion of a housing248 of the medical device 114. The camera may be disposed in apredetermined orientation such that an image or images of the disposablecomponent and an external surface of the apheresis machine housing canbe acquired. In some embodiments, by acquiring the images in responseto, near in time to, or immediately after the error condition has beendetected, useful information about the state of the machine andpotential cause of the error condition can be recorded or retained forfuture analysis. The camera sensor may be configured to log images forevery significant alarm detected by the instrument and stored for laterretrieval either in batch form or individually. In some embodiments,images and/or video may be acquired even before an error condition isdetected, for example in response to a threshold being surpassed for asensed value that is not yet at an alarm state but indicative of apotential future alarm.

In this case, an external housing portion 238 faces substantially upwardtoward the camera sensor, making it easier to acquire a useful image ofthe state of the machine. The camera sensor may be disposed on an arm239 extending horizontally over the external housing portion 238. Thecamera sensor may be coupled to a user interface housing portion 248 ofthe machine. Other configurations are contemplated. The camera sensormay have imaging hardware installed within the camera, such as acharge-coupled device, a complementary metal-oxide-semiconductor device,or other imaging technology. The camera sensor may be configured tosense light waves of different ranges along the electromagneticspectrum, such as visible light, invisible light, infrared light,ultraviolet light, or radiation of other wavelength ranges. For example,sensing infrared light may provide information relating to thetemperature of fluids within the tubing of the disposable component.Acquiring an image of visible light and an image of infrared light maybe provide more information that is useful in diagnosing the cause of anerror condition.

The error condition may be any of a number of conditions. For example,the error condition may be an indication of a failure of a component ora processing step. In response to an error condition, the machine may beconfigured to display on user interface 241 contact information for amanufacturer of the medical machine to a human operator. The userinterface 241 may also prompt a user to instruct the device to senddiagnostic information, including any images acquired, to a servicetechnician's computer via a network.

In some embodiments, an image or images (or video) may be acquired andstored or logged for later retrieval. In one embodiment, the camera mayhave a position and/or orientation that is adjustable by a humanoperator. The camera may have a controllable zoom, focus, tint,brightness, and/or other digital image editing features controllablefrom a user interface of the medical machine. Images may be transmittedmanually or automatically over a network to a predetermined destination(e.g., an IP address, an email address, or other network location), orthe user interface may be used for the human operator to enter alocation address for the remote destination computer. The user interfacemay allow the user to select from among a plurality of images and/orother medical device information to send. Alternatively, the medicaldevice may be programmed to send all images or predetermined medicaldevice information without regard to user input.

Referring now to FIG. 12, a method of recording a state of a medicaldevice will be described according to another embodiment. The medicaldevice may comprise a programmed processing circuit and a disposablecomponent disposed on or installed on an external surface of a medicaldevice housing. At a block 1200, the medical device is operated, forexample in a preparation step, a priming step, a blood processing step,a blood return step, a procedure finalization step, or other steps, suchas providing a software update to the machine, running machinediagnostics, etc. In some embodiments, the device operation of block1200 involves use of the disposable component.

At a block 1202, the medical device is configured to detect an errorcondition on the medical device using the processing circuit. Theprocessing circuit, in response to the detection of the error condition,may be configured to acquire an image (block 1204) from a camera coupledto or built-in to the medical device, the image representing thedisposable component and at least a portion of the external housing ofthe medical device. The image may be acquired directly in response todetection of the error, or the acquisition may be done based at least inpart on the detection of the error and based on other inputs (e.g., suchas a user confirmation to acquire the image). The image may be acquiredimmediately after the detection of the error or shortly after detectionof the error (e.g., within less than 3 seconds of the error, within lessthan 10 seconds of the error, within less than 30 seconds of the error,etc.). The image or video may be acquired even before detection of theerror. The processing circuit may be programmed with threshold valuesfor each sensor on the instrument to trigger an alarm. The processingcircuit may further be programmed to start acquiring images and/or videowhen monitored sensor data reach certain values or thresholds beforereaching the threshold value to trigger an alarm.

At a block 1206, the processing circuit is configured to store the imagein a memory of the medical device, wherein the memory is accessible forlater retrieval of the image. The memory may be a flash drive, a USBmemory stick, random access memory, flash EPROM, EEPROM, hard diskstorage, solid state memory, or other memory types. The memory may havean interface for retrieval of the image, images or other medical deviceinformation, such as an interface bus to a communications network, aninterface circuit to a USB memory card slot, an interface to an SD cardslot, or other interfaces.

The medical device may be configured to only acquire an image (or onlyacquire an image automatically) when an error condition of a certainsignificance or severity is detected. For example, a processing circuitmay detect error conditions of a first type (e.g., more significant) anderror conditions of a second type (less significant). The processingcircuit may acquire the image for errors of the first type and may beconfigured to not acquire the image for error conditions of the secondtype. In some examples, the error conditions of the first type may alsoresult in the processing circuit stopping the medical procedure.

The image may be transmitted to a remote computing device withoutrequiring input from a human operator, e.g., automatically. Inalternative embodiments, the image may be transmitted only after userinput to confirm the transmission. In some embodiments, the image may betransmitted over the network in response to a request message receivedfrom the remote computer over the computer network. For example, themessage may be formatted as an HTTP response message and the remotecomputer may act as a TCP/IP client requesting the message from themedical machine operating as a TCP/IP server computer.

In some embodiments, the camera and processing circuit may be configuredto acquire images for transmission as described herein and also may beconfigured in another mode or use to detect improper installation of thedisposable component. If the camera and processing circuit detectimproper installation (e.g., using image processing techniques), theprocessing circuit may be configured to provide an audible and/or visualalert to a user interface of the medical device in response to detectionof improper installation of the disposable component.

One or more messages described herein may be transmitted to amanufacturer of the medical device and/or the disposable component. Themanufacturer may operate a computer configured to aggregate data frommultiple machines at different facilities in different locationsoperated by different companies. The aggregated data can be processedand analyzed to determine common error conditions, frequent errors ininstalling disposable components, etc., in order to guide futuretraining or troubleshooting processes.

FIG. 14 illustrates another medical instrument, a plasmapheresismachine. This plasmapheresis machine uses a disposable componentcomprising a plasma collection container, a plasma line connector, aplasma line, a cell line, a blood line, an anticoagulant line, a needleconnector, and other components. The plasmapheresis machine comprises atouch screen for user interface functions, a signal light for outputtingvisual indications, a stop button hard key for stopping the machine, andother components. In this embodiment, an external surface of the machinethat interfaces with the distributed component faces substantiallyhorizontally relative to a base or floor beneath the base. A camerasensor is disposed in a portion of the housing extending outward overthe external surface. The portion of the housing comprises the userinterface, stop button and signal light, and a bottom surface thereofmay be coupled to the camera sensor. The camera sensor has a field ofview directed downward in a configuration to capture an image or imagesof portions of the disposable component as well as pumps and othercomponents of the plasmapheresis machine. In one embodiment, the medicalinstrument may have a retractable arm dedicated to the camera sensor,the retractable arm configured to manually or automatically extend apredetermined distance away from the housing and outward at an anglehaving a better view coverage of the disposable installed on theinstrument. In one embodiment, the arm automatically extends in responseto an error condition to acquire images and/or video of the disposablearrangement.

Referring now to FIG. 15, a medical device 1500 comprises a medicaldevice housing having a first housing portion 1506 facing substantiallyhorizontally and hinged to a second housing portion 1504 facingsubstantially vertically, when in a user or operating configuration. Inthis embodiment, a camera 1508 may be configured to image one or both ofhousing portion external surfaces 1506, 1504. Camera 1508 may also beconfigured to image a disposable component 1512 disposed on one or bothexternal surfaces of the medical device housing.

Medical device 1500 may further comprise a programmed processing circuit(internal to the housing) configured to operate the medical device toprovide a medical procedure (such as plasmapheresis, red blood cellcollection, both procedures, or other procedures) using the disposablecomponent. The processing circuit may be configured to detect an errorcondition on the medical device 1500 and, in response to the detectionof the error condition, acquire an image from camera 1508. Theprocessing circuit may further be configured to store the image in amemory of the medical device (internal to the housing), wherein thememory is accessible for later retrieval of the image.

As shown, camera 1508 may be disposed in a position on the housing toimage a plurality of lines of the disposable component and at least oneblood product bag 1510 of the disposable component.

In some embodiments, the programmed processing circuit may be configuredto store a plurality of images, each image acquired in response to adetection of an error condition.

In some embodiments, the medical device may further comprise a networkinterface circuit configured to transmit the stored images over anetwork to a remote computer. A network interface circuit may comprisehardware, software, firmware components, etc., configured to formatmessages for bidirectional communication over a network, such as anEthernet or other network, local area, wide area, Bluetooth network,Wi-Fi network, etc.

In some embodiments, a user interface device 1513 may be coupled to theprogrammed processing circuit. The programmed processing circuit may beconfigured to transmit stored images in response to a user inputprovided via the user interface device. For example, user interfacedevice 1513 may be a touch screen. The processing circuit may beconfigured to prompt a user in the event of an error condition with amessage such as “ACQUIRE DIAGNOSTIC INFORMATION?” or “READY TO ACQUIREIMAGE?” or another prompt. A “CONFIRM” or “OK” input key may be providedby the touch screen for user input to instruct the processing circuit toacquire the image. Similar configurations can be made to solicit userinstruction to transmit the image or other medical device information,select a destination for the transmissions, etc.

In another embodiment, the medical device may be configured to videorecord the disposable component, portion of the external surface of themedical device, and/or other portions of the medical device and itssurroundings. The video may be recorded of an entire procedure, or ofportions of the procedure beyond those relating to an error condition.For example, upon beginning a new procedure, the medical device may beconfigured to begin recording the operator's installation of thedisposable component, the use of the disposable component during theprocedure, and the removal of the disposable component. This video maybe stored in memory for later retrieval if needed. The procedure may beautomatically erased after a period of time (e.g., 1 day, 5 days, 30days, 90 days, etc.). Advantageously, in the case of an adverse event,or for other purposes, the entire procedure from beginning to end may beviewed for investigation.

While illustrative embodiments have been described herein, it will beapparent from the disclosure of varied embodiments that modificationsand alternatives are contemplated in various different embodiments. Forexample, the teachings herein may be applied to other medical devicesusing disposable components, such as infusion pumps using disposablesyringes or medicament bags, feeding pumps using disposable nutrientbags, etc. Also, while detected error conditions are described astriggering image acquisition, other process steps of medical machine maytrigger automatic acquisition of an image, such as the completion of astep of a medical procedure (e.g., a final step, an intermediate step,etc.), or other triggering events.

What is claimed is:
 1. A method of recording a state of an apheresismachine having a disposable component disposed thereon, the disposablecomponent comprising tubing and a blood bag, wherein the disposablecomponent is configured to be installed on the apheresis device by ahuman operator, comprising: detecting an error condition on theapheresis device; providing at least one of an audible alert and avisual alert in response to the detected error condition; acquiring witha camera an image of a forward-facing external surface portion of theapheresis machine and the tubing and the blood bag of the disposablecomponent, wherein the image is acquired automatically without requiringuser input; recording medical device information comprising the image;generating a message comprising the image; and transmitting the messagecomprising the image to a remote computer.
 2. The method of claim 1,wherein the message further comprises an indication of a failure,wherein the message is transmitted to a manufacturer of the component.3. The method of claim 1, further comprising providing contactinformation for the manufacturer to the human operator via a userinterface of the apheresis device.
 4. The method of claim 1, wherein theapheresis machine has imaging hardware installed for the camera.
 5. Themethod of claim 1, wherein the image is acquired automatically inresponse to the error condition.
 6. The method of claim 1, wherein themedical device information comprises a make, model or type of medicaldevice.
 7. A method of recording a state of a medical device having aprogrammed processing circuit and a disposable component disposed on anexternal surface of a medical device housing, wherein the disposablecomponent is configured to be installed on the external surface by ahuman operator and removable therefrom for disposal, comprising:operating the medical device to provide a medical procedure using thedisposable component; detecting an error condition on the medical deviceusing the processing circuit, wherein the processing circuit, inresponse to the detection of the error condition, acquires an image froma camera coupled to the medical device, the image representing portionsof the disposable component comprising a plurality of lines and at leastone blood product bag and ft portions of the external housing of themedical device; and storing the image in a memory of the medical device,wherein the memory is accessible for later retrieval of the image. 8.The method of claim 7, wherein the medical procedure is an apheresisprocedure.
 9. The method of claim 7, wherein the error condition resultsin the processing circuit stopping the medical procedure.
 10. The methodof claim 7, the processing circuit detecting error conditions of a firsttype and error conditions of a second type, wherein the processingcircuit acquires the image when error conditions of the first type aredetected and does not acquire the image when error conditions of thesecond type are detected.
 11. The method of claim 10, further comprisingproviding at least one of a visual and audible alarm on a user interfaceof the medical device in response to the error conditions of the firsttype and the error conditions of the second type.
 12. The method ofclaim 7, further comprising transmitting the image stored in the memoryover a network to a remote computing device without requiring input froma human operator.
 13. The method of claim 7, further comprisingtransmitting the image stored in the memory over a network to a remotecomputing device in response to input from a human operator.
 14. Themethod of claim 7, further comprising receiving a request for the imageover a network at the processing circuit from a remote computer and, inresponse, transmitting the image over the network to the remotecomputer.
 15. The method of claim 7, further comprising using the cameraand processing circuit to detect improper installation of the disposablecomponent and providing an audible and/or visual alert to a userinterface of the medical device in response to detection of improperinstallation of the disposable component.
 16. A medical device,comprising: a medical device housing having an external surface; adisposable component disposed on the external surface of the medicaldevice housing, wherein the disposable component is configured to beinstalled on the external surface by a human operator and removabletherefrom for disposal; a camera coupled to the medical device andconfigured to acquire an image representing the disposable component andat least a portion of the external surface, the camera coupled to themedical device in a position to image a plurality of lines of thedisposable component and at least one blood product bag of thedisposable component; and a programmed processing circuit configured to:operate the medical device to provide a medical procedure using thedisposable component, wherein the medical procedure is an apheresisprocedure, detect an error condition on the medical device, in responseto the detection of the error condition, acquire an image from thecamera; and store the image in a memory of the medical device, whereinthe memory is accessible for later retrieval of the image.
 17. Themedical device of claim 16, wherein the programmed processing circuit isconfigured to store a plurality of images, each image acquired inresponse to a detection of an error condition.
 18. The medical device ofclaim 17, further comprising a network interface circuit configured totransmit the stored images over a network to a remote computer.
 19. Themedical device of claim 18, further comprising a user interface devicecoupled to the programmed processing circuit, wherein the programmedprocessing circuit is configured to transmit the stored images inresponse to a user input provided via the user interface device.